| Primary | Area Under the Concentration (AUC) Time Curve From Time Zero Extrapolated to Infinite Time (AUC [0-infinity]) of DTG | Blood samples were collected at indicated time-points for analysis of AUC (0-infinity) of DTG. PK parameters were calculated by standard non-compartmental analysis. | PK Population included all participants in the Safety Population (participants who were enrolled in the study and received at least one dose of study drug) for whom a PK sample was obtained and had evaluable PK assay results. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | AUC (0-infinity) of RPV | Blood samples were collected at indicated time-points for analysis of AUC (0-infinity) of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Area Under the Concentration Time Curve From Time Zero to Last Time of Quantifiable Concentration (AUC [0-t]) of DTG | Blood samples were collected at indicated time-points for analysis of AUC (0-t) of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | AUC (0-t) of RPV | Blood samples were collected at indicated time-points for analysis of AUC (0-t) of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Maximum Observed Plasma Concentration (Cmax) of DTG | Blood samples were collected at indicated time-points for analysis of Cmax of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Cmax of RPV | Blood samples were collected at indicated time-points for analysis of Cmax of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Absorption Lag Time (Tlag) of DTG | Blood samples were collected at indicated time-points for analysis of tlag of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Median | Full Range | Hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Primary | Tlag of RPV | Blood samples were collected at indicated time-points for analysis of tlag of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Median | Full Range | Hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Primary | Time to Reach Maximum Observed Concentration (Tmax) of DTG | Blood samples were collected at indicated time-points for analysis of tmax of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Median | Full Range | Hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Tmax of RPV | Blood samples were collected at indicated time-points for analysis of tmax of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Median | Full Range | Hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Primary | Time of Last Quantifiable Concentration (Tlast) of DTG | Blood samples were collected at indicated time-points for analysis of tlast of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Median | Full Range | Hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Tlast of RPV | Blood samples were collected at indicated time-points for analysis of tlast of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Median | Full Range | Hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Primary | Elimination Half-life (t1/2) of DTG | Blood samples were collected at indicated time-points for analysis of t1/2 of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | T1/2 of RPV | Blood samples were collected at indicated time-points for analysis of t1/2 of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Apparent Elimination Rate Constant (Lambda z) of DTG | Blood samples were collected at indicated time-points for analysis of lambda z of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Mean | Standard Deviation | Per hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Lambda z of RPV | Blood samples were collected at indicated time-points for analysis of lambda z of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Mean | Standard Deviation | Per hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Percentage of AUC(0-infinity) That Was Extrapolated (%AUCex) of DTG | Blood samples were collected at indicated time-points for analysis of percentage AUCex of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Mean | Standard Deviation | Percentage of AUCex | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Percentage AUCex of RPV | Blood samples were collected at indicated time-points for analysis of percentage AUCex of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Mean | Standard Deviation | Percentage of AUCex | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC[0-24]) of DTG | Blood samples were collected at indicated time-points for analysis of AUC(0-24) of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | AUC (0-24) of RPV | Blood samples were collected at indicated time-points for analysis of AUC (0-24) of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Area Under the Plasma Concentration Time Curve From Time Zero to 72 Hours (AUC[0-72]) of DTG | Blood samples were collected at indicated time-points for analysis of AUC(0-72) of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | AUC (0-72) of RPV | Blood samples were collected at indicated time-points for analysis of AUC (0-72) of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Apparent Oral Clearance (CL/F) of DTG | Blood samples were collected at indicated time-points for analysis of CL/F of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | CL/F of RPV | Blood samples were collected at indicated time-points for analysis of CL/F of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, 264 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Apparent Oral Volume of Distribution (Vz/F) of DTG | Blood samples were collected at indicated time-points for analysis of Vz/F of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Mean | Standard Deviation | Liters | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Vz/F of RPV | Blood samples were collected at indicated time-points for analysis of Vz/F of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Mean | Standard Deviation | Liters | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Primary | Last Quantifiable Concentration (Ct) of DTG | Blood samples were collected at indicated time-points for analysis of Ct of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, and 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Ct of RPV | Blood samples were collected at indicated time-points for analysis of Ct of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 16, 24, 48, 72, 120, 168, 216, and 264 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Primary | Concentration at 24-hour Post-dose (C24) of DTG | Blood samples were collected at indicated time-points for analysis of C24 of DTG. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | At 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Primary | C24 of RPV | Blood samples were collected at indicated time-points for analysis of C24 of RPV. PK parameters were calculated by standard non-compartmental analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | At 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Secondary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose: results in death and is life-threatening; which requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly, or any other situation that require medical or scientific judgment. | Safety Population included participants who were enrolled in the study and received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Up to Day 18 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Change From Baseline in Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, leukocyte, monocytes, eosinophils and basophils. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | Giga cells per liter | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Absolute Values of Neutrophil, Lymphocyte, Leukocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, leukocyte, eosinophils and basophils. Baseline was defined as Day -1. | | Posted | | Mean | Standard Deviation | Giga cells per liter | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Change From Baseline in Hemoglobin Level | Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Absolute Values of Hemoglobin Level | Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Day -1. | | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Secondary | Change From Baseline in Hematocrit Level | Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | Proportion of red blood cells in blood | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Absolute Values of Hematocrit Level | Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1. | | Posted | | Mean | Standard Deviation | Proportion of red blood cells in blood | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Secondary | Change From Baseline in Erythrocytes | Blood samples were collected at indicated timepoints for analysis of hematology parameter like erythrocytes. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | Trillion cells per liter | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Absolute Values of Erythrocytes | Blood samples were collected at indicated timepoints for analysis of hematology parameter like erythrocytes. Baseline was defined as Day -1. | | Posted | | Mean | Standard Deviation | Trillion cells per liter | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Secondary | Change From Baseline in Mean Corpuscular Hemoglobin (MCH) | Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | Picograms | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Absolute Values of MCH | Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1. | | Posted | | Mean | Standard Deviation | Picograms | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Secondary | Change From Baseline in Mean Corpuscular Volume (MCV) | Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCV. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | Femtoliters | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Absolute Values of MCV | Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCV. Baseline was defined as Day -1. | | Posted | | Mean | Standard Deviation | Femtoliters | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Secondary | Change From Baseline in Reticulocytes | Blood samples were collected at indicated timepoints for analysis of hematology parameter like reticulocytes. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | Percentage of reticulocytes | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Absolute Values of Reticulocytes | Blood samples were collected at indicated timepoints for analysis of hematology parameter like reticulocytes. Baseline was defined as Day -1. | | Posted | | Mean | Standard Deviation | Percentage of reticulocytes | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Secondary | Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Sodium, and Potassium Levels | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like (BUN), glucose, sodium, calcium, and potassium levels. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | Millimoles per Liter | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Absolute Values of BUN, Glucose, Calcium, Sodium, and Potassium Levels | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like (BUN), glucose, sodium, calcium, and potassium levels. Baseline was defined as Day -1. | | Posted | | Mean | Standard Deviation | Millimoles per Liter | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
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| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
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| Secondary | Change From Baseline in Total and Direct Bilirubin, Creatinine and Protein Levels | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like total and direct bilirubin, creatinine and protein levels. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
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| Secondary | Absolute Values of Total and Direct Bilirubin, Creatinine and Protein Levels | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like total and direct bilirubin, creatinine and protein levels. Baseline was defined as Day -1. | | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
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| Secondary | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like AST, ALT and ALP levels. Baseline was defined as Day -1. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | International units per Liter | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Absolute Values of AST, ALT and ALP Levels | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters like AST, ALT and ALP levels. Baseline was defined as Day -1. | | Posted | | Mean | Standard Deviation | International units per Liter | | Baseline (Day -1) and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP were assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (Day 1, Pre-dose) and at Day 12 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Absolute Values of SBP and DBP | SBP and DBP were assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline. | | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (Day 1, Pre-dose) and at Day 12 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Secondary | Change From Baseline in Pulse Rate | Pulse rate was assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1, Pre-dose) and at Day 12 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| |
| Secondary | Absolute Values of Pulse Rate | Pulse rate was assessed in the supine position with a completely automated device. Day 1 (Pre-dose) was defined as Baseline. | | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1, Pre-dose) and at Day 12 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Secondary | Change From Baseline in Body Temperature | Body temperature were assessed at indicated time-points. Day 1 (Pre-dose) was defined as Baseline. Change from Baseline was defined as post-dose visit value minus Baseline value. | | Posted | | Mean | Standard Deviation | Degree Celsius | | Baseline (Day 1, Pre-dose) and at Day 12 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |
| Secondary | Absolute Values of Body Temperature | Body temperature were assessed at indicated time-points. Day 1 (Pre-dose) was defined as Baseline. | | Posted | | Mean | Standard Deviation | Degree Celsius | | Baseline (Day 1, Pre-dose) and at Day 12 | | | | ID | Title | Description |
|---|
| OG000 | DTG/RPV 50mg/25mg FDC | Healthy participants were administered single oral FDC tablet of DTG/RPV 50mg/25mg on Day 1 in fed state |
| | |