| Primary | Area Under the Plasma Concentration-time Curve From Time of Dose Extrapolated to Infinite Time (AUC[0-infinity]) of DTG for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic (PK) profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. The PK Population was defined as participants in the All Subjects Population for whom a PK sample was obtained and that had evaluable PK assay results. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours*nanograms/mL (h*ng/mL) | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00058900± 37.2
- OG00158400± 29.3
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Ratio | 1.0084 | | | 2-Sided | 90 | 0.8626 | 1.1789 | | | | | Other | | |
|
| Primary | Area Under the Plasma Concentration-time Curve From Time of Dose to Last Measurable Concentration AUC [0-t] of DTG for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Primary | Maximum Observed Concentration (Cmax) of DTG for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Primary | AUC (0-infinity) of DTG for Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | |
|
| Secondary | AUC (0-t) of DTG for Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | |
|
| Secondary | Cmax of DTG for Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | |
|
| Secondary | Plasma DTG Lag Time Before Observation of Drug Concentrations (Tlag) for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Median | Full Range | hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Secondary | Time to First Occurrence of Cmax (Tmax) of DTG for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Median | Full Range | hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Secondary | Terminal Phase Half-life (t1/2) of DTG for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Secondary | Terminal-phase Rate Constant (Lambda z) of DTG for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | per hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Secondary | Percentage of AUC (0-infinity) Obtained by Extrapolation (%AUCex) of DTG for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Mean | 95% Confidence Interval | Percentage of AUC | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Secondary | Area Under the Concentration-time Curve Over Time Zero (Pre-dose) to 24 Hours After Dose Administration (AUC[0-24]) of DTG for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Secondary | Apparent Oral Clearance (CL/F) of DTG for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters/hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Secondary | Apparent Volume of Distribution During the Terminal Phase (Vz/F) of DTG for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received treatment B in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Secondary | Last Observed Quantifiable Concentration (Ct) of DTG for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Secondary | Observed Concentration at 24 Hours After Dose Administration (C24) of DTG for Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Secondary | Plasma DTG Tlag for Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Median | Full Range | hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
|
| Secondary | Tmax of DTG for Part 2 | Blood sample were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Median | Full Range | hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | Participants in this cross-over study received 25 mg DTG tablet administered as direct to mouth (reference) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
|
| Secondary | t1/2 of DTG for Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | |
|
| Secondary | Lambda Z of DTG for Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times | | Posted | | Geometric Mean | Geometric Coefficient of Variation | per hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | |
|
| Secondary | %AUCex of DTG for Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Mean | 95% Confidence Interval | Percentage of AUC | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | |
|
| Secondary | AUC (0-24) of DTG for Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | |
|
| Secondary | DTG CL/F for Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters/hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received treatment C in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received treatment D in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | Participants in this cross-over study received treatment E in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
|
| Secondary | Vz/F of DTG for Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received treatment C in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received treatment D in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | Participants in this cross-over study received treatment E in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
|
| Secondary | Ct of DTG for Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | |
|
| Secondary | C24 of DTG for Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | DTG 25 mg (Reference) | |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1 | AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Data has been presented for AEs and SAEs up-to follow-up (25 days) in Part 1. All Subjects Population was defined as all participants who received at least 1 dose of study medication. | | Posted | | Number | | Participants | | Up to 25 days in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Number of Participants With Adverse Events AEs and Serious Adverse Events SAEs for Part 2 | AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Data has been presented for AEs and SAEs up-to follow-up (36 days) in Part 2. | | Posted | | Number | | Participants | | Up to 36 days in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum glucose, serum calcium, serum potassium, serum sodium, serum urea results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). | | Posted | | Mean | Standard Deviation | millimoles/liter (mmol/L) | | Baseline and up to 25 days in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum ALT, serum alkaline phosphatase, serum AST, serum creatine kinase results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). | | Posted | | Mean | Standard Deviation | International units/liter (IU/L) | | Baseline and up to 25 days in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum albumin and serum protein results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). | | Posted | | Mean | Standard Deviation | Grams/liter (g/L) | | Baseline and up to 25 days in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Secondary | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum bilirubin, serum creatinine and serum direct bilirubin results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). | | Posted | | Mean | Standard Deviation | micromoles/liter (umol/L) | | Baseline and up to 25 days in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
| |
| Secondary | Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum glucose, serum calcium, serum potassium, serum sodium, serum urea results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). | | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and up to 36 days in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum ALT, serum alkaline phosphatase, serum AST, serum creatine kinase results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). | | Posted | | Mean | Standard Deviation | IU/L | | Baseline and up to 36 days in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum albumin and serum protein results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). | | Posted | | Mean | Standard Deviation | g/L | | Baseline and up to 36 days in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2 | Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum bilirubin, serum creatine and serum direct bilirubin results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). | | Posted | | Mean | Standard Deviation | umol/L | | Baseline and up to 36 days in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Hemoglobin (MCH) for Part 1 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCH results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). | | Posted | | Mean | Standard Deviation | Picograms (pg) | | Baseline and up to 25 days in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Volume (MCV) for Part 1 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCV results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles). | | Posted | | Mean | Standard Deviation | Femtoliters (fL) | | Baseline and up to 25 days in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils, blood platelets results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles) | | Posted | | Mean | Standard Deviation | 10^9 cells/Liter | | Baseline and up to 25 days in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 1 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hemoglobin results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles) | | Posted | | Mean | Standard Deviation | g/L | | Baseline and up to 25 days in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hematocrit results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles). | | Posted | | Mean | Standard Deviation | Proportion of red blood cells in blood | | Baseline and up to 25 days in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 1 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles). | | Posted | | Mean | Standard Deviation | 10^12 cells/Liter | | Baseline and up to 25 days in Part 1 | | | | ID | Title | Description |
|---|
| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Hematology Parameter Blood Erythrocyte MCH for Part 2 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCH results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles). | | Posted | | Mean | Standard Deviation | pg | | Baseline and up to 36 days in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 |
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| Secondary | Change From Baseline in Hematology Parameter Blood Erythrocyte MCV for Part 2 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCV results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles). | | Posted | | Mean | Standard Deviation | fL | | Baseline and up to 36 days in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 |
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| Secondary | Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils, blood platelets results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles) | | Posted | | Mean | Standard Deviation | 10^9 cells/Liter | | Baseline and up to 36 days in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 2 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hemoglobin results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles) | | Posted | | Mean | Standard Deviation | g/L | | Baseline and up to 36 days in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 |
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| Secondary | Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hematocrit results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles) | | Posted | | Mean | Standard Deviation | Proportion of red blood cells in blood | | Baseline and up to 36 days in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | |
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| Secondary | Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 2 | Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocytes results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles). | | Posted | | Mean | Standard Deviation | 10^12 cells/Liter | | Baseline and up to 36 days in Part 2 | | | | ID | Title | Description |
|---|
| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 |
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| Secondary | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood and urine protein. In this dipstick test, the level of ketones, glucose, occult blood and protein in urine samples was recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented. | | Posted | | Number | | Participants | | Up to 25 days in Part 1 | | | | ID | Title | Description |
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| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1 | Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles). | | Posted | | Mean | Standard Deviation | Points on a scale | | Up to 25 days in Part 1 | | | | ID | Title | Description |
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| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Urine Specific Gravity Analysis by Dipstick Method for Part 1 | Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles). | | Posted | | Mean | Standard Deviation | Ratio | | Up to 25 days in Part 1 | | | | ID | Title | Description |
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| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood and urine protein. In this dipstick test, the level of ketones, glucose, occult blood and protein in urine samples was recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented. | | Posted | | Number | | Participants | | Up to 36 days in Part 2 | | | | ID | Title | Description |
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| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Urine pH Analysis by Dipstick Method for Part 2 | Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles). | | Posted | | Mean | Standard Deviation | Points on a scale | | Up to 36 days in Part 2 | | | | ID | Title | Description |
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| OG000 | DTG 5 mg (Test 1) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as a dispersion and immediately taken (test 1) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 5 mg (Test 2) | Participants in this cross-over study received 5 mg dispersible DTG tablet (5 tablets) administered as direct to mouth (test 2) in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Urine Specific Gravity Analysis by Dipstick Method for Part 2 | Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). | | Posted | | Mean | Standard Deviation | Ratio | | Up to 36 days in Part 2 | | | | ID | Title | Description |
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| OG000 | Treatment C | Participants in this cross-over study received treatment C in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | Treatment D | Participants in this cross-over study received treatment D in one of the 3 dosing periods in Part 2 as per randomization schedule. The 3 dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG002 | Treatment E |
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| Secondary | Number of Participants With Chemistry Toxicities of Grade 2 as Defined by Division of Acquired Immunodeficiency Syndrome (DAIDS) for Part 1 | The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life threatening. low LDL (low-density lipid); HDL (high-density lipid). Data has been presented for clinical chemistry laboratory result parameter (serum sodium) with toxicity of Grade 2 for Part 1. | | Posted | | Number | | Participants | | Up to 25 days in Part 1 | | | | ID | Title | Description |
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| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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| Secondary | Number of Participants With Urinalysis Toxicities of Grade 2 as Defined by DAIDS for Part 1 | The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life threatening, low LDL and HDL Data has been presented for urinalysis laboratory result parameter (urine protein by dipstick analysis) with toxicity of Grade 2 for Part 1. | | Posted | | Number | | Participants | | Up to 25 days in Part 1 | | | | ID | Title | Description |
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| OG000 | DTG 10 mg | Participants in this cross-over study received 10 mg DTG tablet (5 tablets) administered direct to mouth (test) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. | | OG001 | DTG 50 mg | Participants in this cross-over study received 50 mg DTG tablet administered direct to mouth (reference) in either of the 2 dosing periods in Part 1 as per randomization schedule. Both the dosing periods were separated by a washout of 7(-4 hours) days between the doses. |
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