| Primary | Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time points for analysis of ambrisentan and tadafil. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 1 of the study. The analysis was performed on Pharmacokinetic (PK) parameter population, which included all participants who provided PK parameter data. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. | | OG002 | Part 1,Treatment F3 | In the F3 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): GSK3380154, TABA, Tablet Weight 560mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently, which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F4. | | OG003 | Part 1,Treatment F4 | In the F4 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): GSK3380154, TAB-A, Tablet Weight 560mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently, which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose R. | | OG004 | Part 1, Treatment R | In the R arm of Part 1, the participants had received the 2 monotherapies ambrisentan 10 mg and tadalafil 40 mg concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. |
| | Units | Counts |
|---|
| Participants | - OG00021
- OG00123
- OG00223
- OG003
|
| | Title | Denominators | Categories |
|---|
| Ambrisentan, Cmax | | | Title | Measurements |
|---|
| - OG000766.29± 18.2
- OG001685.33± 20.5
- OG002738.49± 22.1
- OG003
|
|
| |
| Primary | Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1 | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples were collected at the indicated time-points. The analysis was done under fasting condition post single dose. There is no formal hypothesis tested for Part 1 of the study. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. |
|
| Primary | AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1 | AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples at Part 1, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours. The analysis was done under fasting condition post single dose. The PK Parameter Population was used for analysis. There is no formal hypotheses tested for Part 1 of the study. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | |
|
| Primary | Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2 | Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time-points, of Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies, ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. |
|
| Primary | AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 2, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis, was done under fasting condition post single dose. PK parameter Populatio was used for analysis. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies, ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. |
|
| Primary | AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2 | AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 2, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours. The analysis was done under fasting condition post single dose. PK parameter Population was used for analysis. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies, ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. |
|
| Primary | Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fed and fasting condition post single dose. PK parameter population was used. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. |
|
| Primary | AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48 and 72 hours post-dose. The analysis, was done under fed and fasting conditions post single dose. PK parameter population was used. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. |
|
| Primary | AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A | AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fed and fasting condition post single dose. PK parameter population was used. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. |
|
| Primary | Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment R3 | In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4. |
|
| Primary | AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36,48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK Parameter Population was used for analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment R3 | In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4. |
|
| Primary | AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B | AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used for analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment R3 | In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4. |
|
| Primary | Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B | Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG001 | Part 3B,Treatment R4 | In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days. |
|
| Primary | AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis, was done under fasting conditions post single dose. PK parameter population was used for analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG001 | Part 3B,Treatment R4 | In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days. |
|
| Primary | AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions- Part 3B | AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used for analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG001 | Part 3B,Treatment R4 | In the R4 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 20 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days. |
|
| Secondary | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1 | Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax. | | Posted | | Median | Full Range | Hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. |
|
| Secondary | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2 | Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Median | Full Range | hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies, ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. | | OG002 | Part 2, Treatment FG2 |
|
| Secondary | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A | Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax. | | Posted | | Median | Full Range | Hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. | |
|
| Secondary | Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B | Serial blood samples were collected at the indicated time-points. In Part 3B, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax. | | Posted | | Median | Full Range | Hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG002 | Part 3B,Treatment R3 | |
|
| Secondary | Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1 | t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 milligram (mg) + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg Sodium laurilsulfate (SLS), with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 milligram (mg) + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. |
|
| Secondary | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2 | t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. | | OG002 | Part 2, Treatment FG2 | Participants were administered the FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG2 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG3. |
|
| Secondary | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A | t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. The serial blood samples were assessed at specified timepoints. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. | | OG002 | Part 3A,Treatment R1 |
|
| Secondary | Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B | t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. The serial blood samples were assessed at specified timepoints. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour | | Pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48, and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG002 | Part 3B,Treatment R3 | In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4. |
|
| Secondary | Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product. | | Posted | | Mean | Standard Deviation | Milliliters of Mercury | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. |
|
| Secondary | Change From Baseline in Vital Signs-Heart Rate, Part 1 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. |
|
| Secondary | Change From Baseline in Vital- Temperature, Part 1 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Degree celsius | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. |
|
| Secondary | Change From Baseline in Vital Signs-Respiratory Rate, Part 1 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. |
|
| Secondary | Change From Baseline in Vital- SBP and DBP, Part 2 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Milliliters of Mercury | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. | | OG002 | Part 2, Treatment FG2 | Participants were administered the FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG2 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG3. |
|
| Secondary | Change From Baseline in Vital Signs-Heart Rate, Part 2 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product. | | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. | | OG002 | Part 2, Treatment FG2 | Participants were administered the FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG2 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG3. |
|
| Secondary | Change From Baseline in Vital- Temperature, Part 2 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product. | | Posted | | Mean | Standard Deviation | Degree celsius | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. | | OG002 | Part 2, Treatment FG2 | Participants were administered the FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG2 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG3. |
|
| Secondary | Change From Baseline in Vital Signs-Respiratory Rate, Part 2 | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. | | OG002 | Part 2, Treatment FG2 | Participants were administered the FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG2 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG3. |
|
| Secondary | Change From Baseline in Vital- SBP and DBP, Part 3A | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP, DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Milliliters of Mercury | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. | | OG002 | Part 3A,Treatment R1 | |
|
| Secondary | Change From Baseline in Vital Signs-Heart Rate, Part 3A | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. | | OG002 | Part 3A,Treatment R1 | |
|
| Secondary | Change From Baseline in Vital- Temperature, Part 3A | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Degree Celsius | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. | | OG002 | Part 3A,Treatment R1 | |
|
| Secondary | Change From Baseline in Vital Signs-Respiratory Rate, Part 3A | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. | | OG002 | Part 3A,Treatment R1 | |
|
| Secondary | Change From Baseline in Vital- SBP and DBP, Part 3B | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Milliliters of Mercury | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG002 | Part 3B,Treatment R3 | In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4. |
|
| Secondary | Change From Baseline in Vital Signs-Heart Rate, Part 3B | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for HR. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG002 | Part 3B,Treatment R3 | In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4. |
|
| Secondary | Change From Baseline in Vital- Temperature, Part 3B | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Degree Celsius | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG002 | Part 3B,Treatment R3 | In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4. |
|
| Secondary | Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B | Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. | | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline and Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG002 | Part 3B,Treatment R3 | In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4. |
|
| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings, -Part 1 | 12-lead ECG, was measured in semi-supine position after 5 minutes rest. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis. | | Posted | | Number | | Participants | | Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. |
|
| Secondary | Number of Participants With Abnormal ECG Findings, -Part 2 | 12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis. | | Posted | | Number | | Participants | | Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. | | OG002 | Part 2, Treatment FG2 | Participants were administered the FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG2 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG3. |
|
| Secondary | Number of Participants With Abnormal ECG Findings, -Part 3A | 12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis. | | Posted | | Number | | Participants | | Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. | | OG002 |
|
| Secondary | Number of Participants With Abnormal ECG Findings, -Part 3B | 12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis. | | Posted | | Number | | Participants | | Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG002 | Part 3B,Treatment R3 | In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4. |
|
| Secondary | Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1 | Blood samples were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. | | Posted | | Number | | Participants | | Up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 milligram (mg) + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg Sodium laurilsulfate (SLS), with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 milligram (mg) + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. |
|
| Secondary | Number of Participants With Hematology Values of PCI - Part 2 | Blood samples were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. | | Posted | | Number | | Participants | | Day 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. | | OG002 | Part 2, Treatment FG2 | Participants were administered the FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG2 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG3. |
|
| Secondary | Number of Participants With Hematology Values of PCI - Part 3A | Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. It was conducted at Day 2 (48 hours). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. | | Posted | | Number | | Participants | | Day 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. | | OG002 | Part 3A,Treatment R1 |
|
| Secondary | Number of Participants With Hematology Values of PCI - Part 3B | Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. It was conducted at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. | | Posted | | Number | | Participants | | Day 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG002 | Part 3B,Treatment R3 | In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4. |
|
| Secondary | Number of Participants With Clinical Chemistry Values of PCI- Part1 | Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. | | Posted | | Number | | Participants | | Day 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 milligram (mg) + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg Sodium laurilsulfate (SLS), with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 milligram (mg) + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. |
|
| Secondary | Number of Participants With Clinical Chemistry Values of PCI- Part 2 | Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. | | Posted | | Number | | Participants | | Day 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies, ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. | | OG002 | Part 2, Treatment FG2 | Participants were administered the FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG2 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG3. |
|
| Secondary | Number of Participants With Clinical Chemistry Values of PCI- Part 3A | Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. | | Posted | | Number | | Participants | | Day 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. | | OG002 | Part 3A,Treatment R1 |
|
| Secondary | Number of Participants With Clinical Chemistry Values of PCI- Part 3B | Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis. | | Posted | | Number | | Participants | | Day 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG002 | Part 3B,Treatment R3 | In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4. |
|
| Secondary | Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1 | Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis. | | Posted | | Number | | Participants | | Up to Day 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. |
|
| Secondary | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2 | Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis | | Posted | | Number | | Participants | | Up to Day 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 milligram (mg) + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. | | OG002 | Part 2, Treatment FG2 | Participants were administered the FDC-G2 granulation size 2 (ambrisentan 10 mg + tadalafil 40 mg) from the formulation selected from Part 1. FG2 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG3. |
|
| Secondary | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A | Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis. | | Posted | | Number | | Participants | | Up to Day 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. | | OG002 | Part 3A,Treatment R1 |
|
| Secondary | Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B | Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis. | | Posted | | Number | | Participants | | Up to Day 2 | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG002 | Part 3B,Treatment R3 | In the R3 arm of Part 3B, which evaluated bioequivalence, the participants had received the 2 monotherapies, for ambrisentan 5 mg and tadalafil 40 mg, under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose of R4. |
|
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis. | | Posted | | Number | | Participants | | Up to 42 days | | | | ID | Title | Description |
|---|
| OG000 | Part 1,Treatment F1 | In the F1 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC1- GSK3380154, TAB-A, Tablet Weight 840mg/2mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F2. | | OG001 | Part 1,Treatment F2 | In the F2 arm of Part 1, the participants had received the FDC with dose session as (ambrisentan 10 mg + tadalafil 40 mg): FDC2- GSK3380154, TAB-A, Tablet Weight 840mg/4mg SLS, with reference to the 2 monotherapy components for ambrisentan 10 mg and tadalafil 40 mg, which were taken concurrently which evaluated bioavailability. This was received as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose F3. |
|
| Secondary | Number of Participants With SAEs and AEs-Part 2 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis. | | Posted | | Number | | Participants | | Up to 35 days | | | | ID | Title | Description |
|---|
| OG000 | Part 2, Treatment R | Participants were administered 2 monotherapies ambrisentan and tadalafil concurrently. The tablets were taken as single oral dose, under fasting condition and was followed by a wash-out period of 7-days. | | OG001 | Part 2, Treatment FG1 | Participants were administered the FDC-G1 granulation size 1 (ambrisentan 10 mg + tadalafil 40 mg) , from the formulation selected from Part 1. FG1 was administered as a single oral dose, under fasting condition and was followed by a wash-out period of 7-days, before the start of next dose FG2. | | OG002 | Part 2, Treatment FG2 |
|
| Secondary | Number of Participants With SAEs and AEs-Part 3A | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis. | | Posted | | Number | | Participants | | Up to 44 days | | | | ID | Title | Description |
|---|
| OG000 | Part 3A,Treatment X1 | In the X1 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg) either FG1, FG2 or FG3 (from granular formulation selected from Part 2), under fed state as a single oral dose. The fed state, participants received a high fat diet. This was followed by a wash-out period of 10-days, before the start of next dose X2. | | OG001 | Part 3A,Treatment X2 | In the X2 arm of Part 3A, which evaluated the bioequivalence, the participants had received FDC (ambrisentan 10 mg + tadalafil 40 mg), either FG1, FG2 or FG3 (the granular formulation selected from Part 2), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R1. |
|
| Secondary | Number of Participants With SAEs and AEs-Part 3B | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis. | | Posted | | Number | | Participants | | Up to 44 days | | | | ID | Title | Description |
|---|
| OG000 | Part 3B,Treatment Y1 | In the Y1 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 40 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose Y2 | | OG001 | Part 3B,Treatment Y2 | In the Y2 arm of Part 3B, which evaluated bioequivalence, the participants had received FDC (ambrisentan 5 mg + tadalafil 20 mg), under fasted state as a single oral dose. This was followed by a wash-out period of 10-days, before the start of next dose R3. | | OG002 | Part 3B,Treatment R3 |
|