Infection, Human Immunodeficiency Virus
Conditions
Keywords
FDC, Lamivudine, Bio-equivalence, Dolutegravir, HIV
Brief summary
This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects. The study will be carried out in two parts. Part 1 of the study will be open label, up to 3 periods design with a wash out period of at least 7 days between treatment periods. Subjects will be randomized to receive either single entities or formulation 1 FDC of DTG and 3TC in a crossover manner in first 2 periods. The first 16 subjects who complete the first two treatment periods and consent to continue will receive a single dose of FDC formulation 1 tablet administered with a high fat meal for a third treatment period. In Part 2 of the study, subjects will be randomized to receive either single entities or formulation 2 FDC of DTG and 3TC in a crossover manner in first 2 periods. Similarly the first 16 subjects will then receive FDC formulation 2 tablets with high fat meal in treatment period 3. Subjects will have a follow-up visit within 7-14 days after the last dose of study drug. Approximately 76 healthy subjects will be included in Part 1 of the study and if Part 2 of the study is conducted, another 76 healthy subjects will be included. The total duration will be approximately 11 weeks.
Interventions
DRUGDolutegravir
Single dose of DTG 50 mg tablet along with 3TC (EPIVIR) tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water. DTG will be a white, film coated, round tablet engraved with SV 572 on one side and 50 on the other side.
DRUGLamivudine
Single dose 3TC (commercial name: EPIVIR) 300 mg tablet along with DTG tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water.\<br\>3TC will be gray, diamond shaped tablet, engraved GX EJ7 on one side and plain on the other side.
DRUGDolutegravir + Lamivudine FDC Formulation 1
Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 1 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) of Part 1 and the first 16 subjects in treatment period 3 (under fed) of Part 1 with 240 mL of room temperature water. <br>FDC formulation 1 tablets will be oval, biconvex, white, film coated tablet engraved 'SV H7I' on one face.
DRUGDolutegravir + Lamivudine FDC Formulation 2
Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 2 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) and the first 16 subjects in treatment period 3 (under fed) of Part 2 with 240 mL of room temperature water. <br>FDC formulation 2 tablets will be oval, biconvex, white, film coated tablet engraved 'SV 13N' on one face.
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18 and 55 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac evaluation (history, electrocardiogram \[ECG\]). * A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Subject must be able to swallow 2 tablets at the same time (Reference tablets only). * Body weight \>=50 kilogram (kg) for men and \>=45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg per meter square (kg/m\^2). * Male or Female. Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine human chorionic gonadotrophin \[hCG\] test), not lactating, and at least one of the following conditions applies: 1. non-reproductive potential defined as: pre-menopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea; in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. 2. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer after the last dose of study medication and completion of the follow-up visit. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at given time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted conditions in Periods 1 and 2 of Part 2. |
| Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Cmax of Plasma DTG and 3TC in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| t1/2 of DTG and 3TC in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2 |
| Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Lambda z of DTG and 3TC in in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| AUC(0-24) of DTG and 3TC in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| CL/F of DTG and 3TC in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Vz/F of DTG and 3TC in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| C24 of DTG and 3TC in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Clast of DTG and 3TC in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Cmax of Plasma DTG and 3TC in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Cmax of Plasma DTG and 3TC in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Tlag of DTG and 3TC in Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Tlag of DTG and 3TC in Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Tmax of DTG and 3TC in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Tmax of DTG and 3TC in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| T1/2 of DTG and 3TC in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| T1/2 of DTG and 3TC in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Lambda z of DTG and 3TC in in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Lambda z of DTG and 3TC in in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Clast of DTG and 3TC in in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Clast of DTG and 3TC in in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| AUC(0-24) of DTG and 3TC in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| AUC(0-24) of DTG and 3TC in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| CL/F of DTG and 3TC in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| CL/F of DTG and 3TC in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Tlast of DTG and 3TC in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Tlast of DTG and 3TC in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Vz/F of DTG and 3TC in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Vz/F of DTG and 3TC in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| C24 of DTG and 3TC in the Fed State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| C24 of DTG and 3TC in the Fed State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | Up to Day 31 in Part 1 and Part 2 | SBP and DBP were measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for SBP and DBP for Part 1 and 2 is presented. |
| Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | Up to Week 11 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE are presented. |
| Change From Baseline in Heart Rate (HR): Part 1 and 2 | Up to Day 31 in Part 1 and Part 2 | HR was measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for HR for Part 1 and 2 is presented. |
| Tlag of DTG and 3TC in Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Tmax of DTG and 3TC in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2 |
| Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Tlast of DTG and 3TC in the Fasted State: Part 2 | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2 |
Countries
United States
Participant flow
Recruitment details
The study was conducted in 2 parts (Part 1 and Part 2) at a single center in the United States from 27-March-2017 to 18-August-2017 and 154 participants (78 in Part 1 and 76 in Part 2) were randomized. First 16 participants completing the first 2 dosing periods, returned for a 3rd treatment period and received single dose of FDC with high fat meal
Pre-assignment details
A total of 283 (Part 1: 150, Part 2: 133) participants were screened for this study; 125 (Part 1: 72, Part2: 53) participants were screen failures (SF) and 4 participants were reserved but not used. The reasons for SF: inclusion/exclusion criteria not met (105), withdrew consent (18), physician decision (2).
Participants by arm
| Arm | Count |
|---|---|
| Part 1 Participants were randomized into treatment sequence A/B (treatment A in Period 1 followed by B in Period 2) or B/A (treatment B in Period 1 followed by A in Period 2), where A=dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet and treatment B= DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period. In treatment periods 1 and 2, single dose of the treatments were administered in the fasted state. | 78 |
| Part 2 Participants were randomized into treatment sequence A/C (treatment A in Period 1 followed by C in Period 2) or C/A (treatment C in Period 1 followed by A in Period 2), where A=DTG 50 mg tablet plus a single 3TC tablet and treatment C= DTG 50 mg/3TC 300 mg FDC bilayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period. | 76 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Treatment Period 1 (4 Days) | Adverse Event | 0 | 1 | 0 | 0 |
| Washout Period 1 (7 Days) | Adverse Event | 0 | 1 | 0 | 1 |
| Washout Period 1 (7 Days) | Lost to Follow-up | 2 | 0 | 1 | 0 |
| Washout Period 1 (7 Days) | Physician Decision | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 2 | Total | Part 1 |
|---|---|---|---|
| Age, Continuous | 31.6 Years STANDARD_DEVIATION 11.18 | 30.5 Years STANDARD_DEVIATION 10.33 | 29.4 Years STANDARD_DEVIATION 9.37 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 7 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian- Central/South Asian Heritage | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian- East Asian Heritage | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian- South East Asian Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 23 Participants | 43 Participants | 20 Participants |
| Race/Ethnicity, Customized White-White/Caucasian/European Heritage | 50 Participants | 100 Participants | 50 Participants |
| Sex: Female, Male Female | 26 Participants | 51 Participants | 25 Participants |
| Sex: Female, Male Male | 50 Participants | 103 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 76 | 0 / 16 | 0 / 75 | 0 / 75 | 0 / 16 |
| other Total, other adverse events | 2 / 75 | 5 / 76 | 1 / 16 | 8 / 75 | 6 / 75 | 1 / 16 |
| serious Total, serious adverse events | 0 / 75 | 0 / 76 | 0 / 16 | 0 / 75 | 0 / 75 | 0 / 16 |
Outcome results
Primary
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter Bioequivalence (BE) Summary Population comprised of all participants who have evaluable PK parameters for both analytes and for both Period 1 and Period 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1 | DTG | 43.1456 Hour*micrograms per milliliter | Geometric Coefficient of Variation 39.29 |
| A: DTG 50 mg + EPIVIR 300 mg | Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1 | 3TC | 12.3337 Hour*micrograms per milliliter | Geometric Coefficient of Variation 19.88 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1 | DTG | 54.8793 Hour*micrograms per milliliter | Geometric Coefficient of Variation 31.6 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1 | 3TC | 12.7603 Hour*micrograms per milliliter | Geometric Coefficient of Variation 19.77 |
90% CI: [1.1894, 1.3582]
90% CI: [1.0097, 1.0591]
Primary
Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1 | DTG | 41.4207 Hours*micrograms per milliliter | Geometric Coefficient of Variation 39.36 |
| A: DTG 50 mg + EPIVIR 300 mg | Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1 | 3TC | 12.1571 Hours*micrograms per milliliter | Geometric Coefficient of Variation 20.19 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1 | DTG | 52.8754 Hours*micrograms per milliliter | Geometric Coefficient of Variation 31.16 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1 | 3TC | 12.6147 Hours*micrograms per milliliter | Geometric Coefficient of Variation 19.75 |
90% CI: [1.1919, 1.3651]
90% CI: [1.0116, 1.0634]
Primary
AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at given time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted conditions in Periods 1 and 2 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2 | DTG, n= 74,74 | 47.2391 Hours*micrograms per milliliter | Geometric Coefficient of Variation 40.29 |
| A: DTG 50 mg + EPIVIR 300 mg | AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2 | 3TC, n= 73,74 | 12.7713 Hours*micrograms per milliliter | Geometric Coefficient of Variation 18.63 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2 | DTG, n= 74,74 | 54.5594 Hours*micrograms per milliliter | Geometric Coefficient of Variation 32.12 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2 | 3TC, n= 73,74 | 13.5624 Hours*micrograms per milliliter | Geometric Coefficient of Variation 17.94 |
90% CI: [1.0699, 1.2468]
90% CI: [1.0413, 1.0861]
Primary
AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2 | DTG | 45.2043 Hour*microgram/milliliter | Geometric Coefficient of Variation 39.57 |
| A: DTG 50 mg + EPIVIR 300 mg | AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2 | 3TC | 12.4790 Hour*microgram/milliliter | Geometric Coefficient of Variation 19.19 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2 | DTG | 52.3372 Hour*microgram/milliliter | Geometric Coefficient of Variation 31.46 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2 | 3TC | 13.3552 Hour*microgram/milliliter | Geometric Coefficient of Variation 18.1 |
90% CI: [1.0718, 1.2507]
90% CI: [1.0464, 1.0946]
Primary
Cmax of Plasma DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Cmax of Plasma DTG and 3TC in the Fasted State: Part 2 | DTG | 2.5531 Micrograms per milliliter | Geometric Coefficient of Variation 36.38 |
| A: DTG 50 mg + EPIVIR 300 mg | Cmax of Plasma DTG and 3TC in the Fasted State: Part 2 | 3TC | 2.4428 Micrograms per milliliter | Geometric Coefficient of Variation 28.25 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Cmax of Plasma DTG and 3TC in the Fasted State: Part 2 | DTG | 2.9132 Micrograms per milliliter | Geometric Coefficient of Variation 30.55 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Cmax of Plasma DTG and 3TC in the Fasted State: Part 2 | 3TC | 3.2185 Micrograms per milliliter | Geometric Coefficient of Variation 29.3 |
90% CI: [1.0533, 1.2361]
90% CI: [1.2616, 1.376]
Primary
Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1 | DTG | 2.4065 Micrograms per milliliter | Geometric Coefficient of Variation 38.95 |
| A: DTG 50 mg + EPIVIR 300 mg | Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1 | 3TC | 2.6650 Micrograms per milliliter | Geometric Coefficient of Variation 29.04 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1 | DTG | 3.0817 Micrograms per milliliter | Geometric Coefficient of Variation 31.86 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1 | 3TC | 3.1885 Micrograms per milliliter | Geometric Coefficient of Variation 28.07 |
90% CI: [1.189, 1.379]
90% CI: [1.1437, 1.2498]
Secondary
Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1 | DTG | 0.0000 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1 | 3TC | 0.0000 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1 | DTG | 0.0000 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1 | 3TC | 0.0000 Hour |
90% CI: [0, 0]
90% CI: [0, 0]
Secondary
Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1 | DTG | 0.0472 Per hour |
| A: DTG 50 mg + EPIVIR 300 mg | Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 0.0407 Per hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1 | DTG | 0.0470 Per hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 0.0400 Per hour |
Secondary
Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1 | DTG | 1.1589 Liters per hour | Geometric Coefficient of Variation 39.29 |
| A: DTG 50 mg + EPIVIR 300 mg | Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 24.3236 Liters per hour | Geometric Coefficient of Variation 19.88 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1 | DTG | 0.9111 Liters per hour | Geometric Coefficient of Variation 31.6 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 23.5104 Liters per hour | Geometric Coefficient of Variation 19.77 |
90% CI: [0.7363, 0.8408]
90% CI: [0.9442, 0.9904]
Secondary
Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1 | DTG | 24.6254 Liters | Geometric Coefficient of Variation 37.8 |
| A: DTG 50 mg + EPIVIR 300 mg | Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 616.7365 Liters | Geometric Coefficient of Variation 34.52 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1 | DTG | 19.3399 Liters | Geometric Coefficient of Variation 30.05 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 598.8651 Liters | Geometric Coefficient of Variation 29.07 |
90% CI: [0.7318, 0.844]
90% CI: [0.9157, 1.0284]
Secondary
AUC(0-24) of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | AUC(0-24) of DTG and 3TC in the Fasted State: Part 2 | DTG | 31.5664 Hours*microgram per milliliter | Geometric Coefficient of Variation 37.73 |
| A: DTG 50 mg + EPIVIR 300 mg | AUC(0-24) of DTG and 3TC in the Fasted State: Part 2 | 3TC | 11.6419 Hours*microgram per milliliter | Geometric Coefficient of Variation 20.23 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC(0-24) of DTG and 3TC in the Fasted State: Part 2 | DTG | 36.6126 Hours*microgram per milliliter | Geometric Coefficient of Variation 30.93 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC(0-24) of DTG and 3TC in the Fasted State: Part 2 | 3TC | 12.5810 Hours*microgram per milliliter | Geometric Coefficient of Variation 18.5 |
90% CI: [1.0711, 1.256]
90% CI: [1.0539, 1.1081]
Secondary
AUC(0-24) of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | AUC(0-24) of DTG and 3TC in the Fed State: Part 1 | DTG | 43.1879 Hour*microgram per milliliter | Geometric Coefficient of Variation 29.88 |
| A: DTG 50 mg + EPIVIR 300 mg | AUC(0-24) of DTG and 3TC in the Fed State: Part 1 | 3TC | 12.6113 Hour*microgram per milliliter | Geometric Coefficient of Variation 21.25 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC(0-24) of DTG and 3TC in the Fed State: Part 1 | DTG | 46.8555 Hour*microgram per milliliter | Geometric Coefficient of Variation 16.95 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC(0-24) of DTG and 3TC in the Fed State: Part 1 | 3TC | 11.8076 Hour*microgram per milliliter | Geometric Coefficient of Variation 18.71 |
90% CI: [0.9613, 1.2245]
90% CI: [0.8913, 0.9836]
Secondary
AUC(0-24) of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | AUC(0-24) of DTG and 3TC in the Fed State: Part 2 | DTG | 38.6325 Hour*microgram per milliliter | Geometric Coefficient of Variation 34.53 |
| A: DTG 50 mg + EPIVIR 300 mg | AUC(0-24) of DTG and 3TC in the Fed State: Part 2 | 3TC | 13.7012 Hour*microgram per milliliter | Geometric Coefficient of Variation 19.24 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC(0-24) of DTG and 3TC in the Fed State: Part 2 | DTG | 48.2012 Hour*microgram per milliliter | Geometric Coefficient of Variation 15.53 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC(0-24) of DTG and 3TC in the Fed State: Part 2 | 3TC | 12.1065 Hour*microgram per milliliter | Geometric Coefficient of Variation 21.09 |
90% CI: [1.1013, 1.4136]
90% CI: [0.8351, 0.935]
Secondary
AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter food effect (FD) Summary Population comprised of participants who participated in the food effect part of the study and had evaluable PK parameters for both fed and fasted administration of the FDC tablet formulation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1 | DTG | 62.3435 Hours*microgram per milliliter | Geometric Coefficient of Variation 32.34 |
| A: DTG 50 mg + EPIVIR 300 mg | AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1 | 3TC | 13.4357 Hours*microgram per milliliter | Geometric Coefficient of Variation 21.02 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1 | DTG | 71.9777 Hours*microgram per milliliter | Geometric Coefficient of Variation 19.99 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1 | 3TC | 12.8668 Hours*microgram per milliliter | Geometric Coefficient of Variation 18.5 |
90% CI: [1.0208, 1.3058]
90% CI: [0.9126, 1.0049]
Secondary
AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2 | DTG | 57.6561 Hours*microgram per milliliter | Geometric Coefficient of Variation 35.93 |
| A: DTG 50 mg + EPIVIR 300 mg | AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2 | 3TC | 14.6420 Hours*microgram per milliliter | Geometric Coefficient of Variation 18.5 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2 | DTG | 76.4283 Hours*microgram per milliliter | Geometric Coefficient of Variation 22.36 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2 | 3TC | 13.3443 Hours*microgram per milliliter | Geometric Coefficient of Variation 20.34 |
90% CI: [1.1837, 1.4845]
90% CI: [0.8658, 0.9593]
Secondary
AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1 | DTG | 60.3212 Hour*microgram per milliliter | Geometric Coefficient of Variation 31.78 |
| A: DTG 50 mg + EPIVIR 300 mg | AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1 | 3TC | 13.2818 Hour*microgram per milliliter | Geometric Coefficient of Variation 20.9 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1 | DTG | 69.2560 Hour*microgram per milliliter | Geometric Coefficient of Variation 18.92 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1 | 3TC | 12.6491 Hour*microgram per milliliter | Geometric Coefficient of Variation 18.63 |
90% CI: [1.0154, 1.2982]
90% CI: [0.9086, 0.9983]
Secondary
AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2 | DTG | 55.2176 Hour*microgram per milliliter | Geometric Coefficient of Variation 35.33 |
| A: DTG 50 mg + EPIVIR 300 mg | AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2 | 3TC | 14.4706 Hour*microgram per milliliter | Geometric Coefficient of Variation 18.72 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2 | DTG | 72.7545 Hour*microgram per milliliter | Geometric Coefficient of Variation 20.22 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2 | 3TC | 13.0923 Hour*microgram per milliliter | Geometric Coefficient of Variation 20.57 |
90% CI: [1.175, 1.4775]
90% CI: [0.8592, 0.9528]
Secondary
AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1 | DTG | 29.4257 Hours*microgram per milliliter | Geometric Coefficient of Variation 38.4 |
| A: DTG 50 mg + EPIVIR 300 mg | AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 11.3960 Hours*microgram per milliliter | Geometric Coefficient of Variation 20.92 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1 | DTG | 37.6112 Hours*microgram per milliliter | Geometric Coefficient of Variation 30.28 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 11.9418 Hours*microgram per milliliter | Geometric Coefficient of Variation 20.09 |
90% CI: [1.1931, 1.3676]
90% CI: [1.0185, 1.0773]
Secondary
C24 of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | C24 of DTG and 3TC in the Fasted State: Part 2 | DTG | 0.7065 Micrograms per milliliter | Geometric Coefficient of Variation 41.48 |
| A: DTG 50 mg + EPIVIR 300 mg | C24 of DTG and 3TC in the Fasted State: Part 2 | 3TC | 0.0366 Micrograms per milliliter | Geometric Coefficient of Variation 30.39 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | C24 of DTG and 3TC in the Fasted State: Part 2 | DTG | 0.8071 Micrograms per milliliter | Geometric Coefficient of Variation 33.83 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | C24 of DTG and 3TC in the Fasted State: Part 2 | 3TC | 0.0350 Micrograms per milliliter | Geometric Coefficient of Variation 31.19 |
90% CI: [1.0597, 1.2317]
90% CI: [0.9299, 0.9804]
Secondary
C24 of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | C24 of DTG and 3TC in the Fed State: Part 1 | DTG | 0.9216 Micrograms per milliliter | Geometric Coefficient of Variation 36.08 |
| A: DTG 50 mg + EPIVIR 300 mg | C24 of DTG and 3TC in the Fed State: Part 1 | 3TC | 0.0304 Micrograms per milliliter | Geometric Coefficient of Variation 33.07 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | C24 of DTG and 3TC in the Fed State: Part 1 | DTG | 1.1916 Micrograms per milliliter | Geometric Coefficient of Variation 25.03 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | C24 of DTG and 3TC in the Fed State: Part 1 | 3TC | 0.0366 Micrograms per milliliter | Geometric Coefficient of Variation 35.9 |
90% CI: [1.1281, 1.4819]
90% CI: [1.1074, 1.3036]
Secondary
C24 of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | C24 of DTG and 3TC in the Fed State: Part 2 | DTG | 0.8355 Micrograms per milliliter | Geometric Coefficient of Variation 38.46 |
| A: DTG 50 mg + EPIVIR 300 mg | C24 of DTG and 3TC in the Fed State: Part 2 | 3TC | 0.0350 Micrograms per milliliter | Geometric Coefficient of Variation 39.91 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | C24 of DTG and 3TC in the Fed State: Part 2 | DTG | 1.2273 Micrograms per milliliter | Geometric Coefficient of Variation 25.73 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | C24 of DTG and 3TC in the Fed State: Part 2 | 3TC | 0.0417 Micrograms per milliliter | Geometric Coefficient of Variation 38.62 |
90% CI: [1.3009, 1.6588]
90% CI: [1.1142, 1.2785]
Secondary
Change From Baseline in Heart Rate (HR): Part 1 and 2
HR was measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for HR for Part 1 and 2 is presented.
Time frame: Up to Day 31 in Part 1 and Part 2
Population: Safety Population. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X,X,X in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 2,n=74,75,16,75,75,16 | 2.2 Beats per minute | Standard Deviation 5.53 |
| A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 4,n=73,75,16,75,75,16 | 7.5 Beats per minute | Standard Deviation 9.28 |
| A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Heart Rate (HR): Part 1 and 2 | 4 hour,n=75,76,16,75,75,16 | 0.6 Beats per minute | Standard Deviation 5.49 |
| A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 3,n=74,75,16,75,75,16 | 5.1 Beats per minute | Standard Deviation 8.15 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 2,n=74,75,16,75,75,16 | 1.9 Beats per minute | Standard Deviation 4.6 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Change From Baseline in Heart Rate (HR): Part 1 and 2 | 4 hour,n=75,76,16,75,75,16 | 0.4 Beats per minute | Standard Deviation 4.25 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 3,n=74,75,16,75,75,16 | 6.0 Beats per minute | Standard Deviation 6.35 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 4,n=73,75,16,75,75,16 | 8.9 Beats per minute | Standard Deviation 7.68 |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 4,n=73,75,16,75,75,16 | 9.6 Beats per minute | Standard Deviation 9.15 |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 2,n=74,75,16,75,75,16 | 2.9 Beats per minute | Standard Deviation 4.17 |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 3,n=74,75,16,75,75,16 | 5.8 Beats per minute | Standard Deviation 6.8 |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Change From Baseline in Heart Rate (HR): Part 1 and 2 | 4 hour,n=75,76,16,75,75,16 | 4.9 Beats per minute | Standard Deviation 3.84 |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 3,n=74,75,16,75,75,16 | 5.3 Beats per minute | Standard Deviation 7.23 |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Heart Rate (HR): Part 1 and 2 | 4 hour,n=75,76,16,75,75,16 | 0.1 Beats per minute | Standard Deviation 5.25 |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 2,n=74,75,16,75,75,16 | 1.6 Beats per minute | Standard Deviation 5.48 |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 4,n=73,75,16,75,75,16 | 8.9 Beats per minute | Standard Deviation 8.31 |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 2,n=74,75,16,75,75,16 | 0.6 Beats per minute | Standard Deviation 5.74 |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 4,n=73,75,16,75,75,16 | 6.1 Beats per minute | Standard Deviation 8.39 |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 3,n=74,75,16,75,75,16 | 3.8 Beats per minute | Standard Deviation 7.13 |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Change From Baseline in Heart Rate (HR): Part 1 and 2 | 4 hour,n=75,76,16,75,75,16 | -0.3 Beats per minute | Standard Deviation 5.43 |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 4,n=73,75,16,75,75,16 | 9.5 Beats per minute | Standard Deviation 10.1 |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Change From Baseline in Heart Rate (HR): Part 1 and 2 | 4 hour,n=75,76,16,75,75,16 | 3.0 Beats per minute | Standard Deviation 3.22 |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 2,n=74,75,16,75,75,16 | 1.6 Beats per minute | Standard Deviation 5.44 |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Change From Baseline in Heart Rate (HR): Part 1 and 2 | Day 3,n=74,75,16,75,75,16 | 7.7 Beats per minute | Standard Deviation 10.42 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2
SBP and DBP were measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for SBP and DBP for Part 1 and 2 is presented.
Time frame: Up to Day 31 in Part 1 and Part 2
Population: Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X,X,X in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 2,n=74,75,16,75,75,16 | -0.5 Millimeters of mercury | Standard Deviation 6.88 |
| A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 3,n=74,75,16,75,75,16 | 4.0 Millimeters of mercury | Standard Deviation 6.67 |
| A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,4 hour,n=75,76,16,75,75,16 | 0.1 Millimeters of mercury | Standard Deviation 5.85 |
| A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 4,n=73,75,16,75,75,16 | 8.2 Millimeters of mercury | Standard Deviation 8.09 |
| A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 4,n=73,75,16,75,75,16 | 7.4 Millimeters of mercury | Standard Deviation 6.47 |
| A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,4 hour,n=75,76,16,75,75,16 | 1.5 Millimeters of mercury | Standard Deviation 6.12 |
| A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 3,n=74,75,16,75,75,16 | 3.2 Millimeters of mercury | Standard Deviation 6.83 |
| A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 2,n=74,75,16,75,75,16 | -0.3 Millimeters of mercury | Standard Deviation 5.53 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 3,n=74,75,16,75,75,16 | 2.7 Millimeters of mercury | Standard Deviation 6.15 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,4 hour,n=75,76,16,75,75,16 | 0.6 Millimeters of mercury | Standard Deviation 5.94 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 4,n=73,75,16,75,75,16 | 7.5 Millimeters of mercury | Standard Deviation 8.43 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,4 hour,n=75,76,16,75,75,16 | 0.2 Millimeters of mercury | Standard Deviation 5.24 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 4,n=73,75,16,75,75,16 | 5.4 Millimeters of mercury | Standard Deviation 6.64 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 2,n=74,75,16,75,75,16 | -0.9 Millimeters of mercury | Standard Deviation 6.14 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 3,n=74,75,16,75,75,16 | 2.7 Millimeters of mercury | Standard Deviation 5.95 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 2,n=74,75,16,75,75,16 | -1.4 Millimeters of mercury | Standard Deviation 6.05 |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,4 hour,n=75,76,16,75,75,16 | -2.1 Millimeters of mercury | Standard Deviation 4.19 |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 2,n=74,75,16,75,75,16 | 0.4 Millimeters of mercury | Standard Deviation 3.91 |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 4,n=73,75,16,75,75,16 | 7.0 Millimeters of mercury | Standard Deviation 5.8 |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 4,n=73,75,16,75,75,16 | 6.1 Millimeters of mercury | Standard Deviation 4.22 |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 3,n=74,75,16,75,75,16 | 1.3 Millimeters of mercury | Standard Deviation 5.19 |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 3,n=74,75,16,75,75,16 | 2.9 Millimeters of mercury | Standard Deviation 4.84 |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 2,n=74,75,16,75,75,16 | 0.4 Millimeters of mercury | Standard Deviation 5.32 |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,4 hour,n=75,76,16,75,75,16 | -0.8 Millimeters of mercury | Standard Deviation 5.49 |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 4,n=73,75,16,75,75,16 | 7.0 Millimeters of mercury | Standard Deviation 8.86 |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,4 hour,n=75,76,16,75,75,16 | 0.0 Millimeters of mercury | Standard Deviation 5.04 |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,4 hour,n=75,76,16,75,75,16 | -0.5 Millimeters of mercury | Standard Deviation 4.09 |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 2,n=74,75,16,75,75,16 | -1.7 Millimeters of mercury | Standard Deviation 4.87 |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 3,n=74,75,16,75,75,16 | 1.7 Millimeters of mercury | Standard Deviation 5.74 |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 4,n=73,75,16,75,75,16 | 4.9 Millimeters of mercury | Standard Deviation 6.51 |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 2,n=74,75,16,75,75,16 | -1.5 Millimeters of mercury | Standard Deviation 5.1 |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 3,n=74,75,16,75,75,16 | 1.9 Millimeters of mercury | Standard Deviation 7.28 |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 4,n=73,75,16,75,75,16 | 7.2 Millimeters of mercury | Standard Deviation 8.72 |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 3,n=74,75,16,75,75,16 | 1.2 Millimeters of mercury | Standard Deviation 6.09 |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 3,n=74,75,16,75,75,16 | 1.6 Millimeters of mercury | Standard Deviation 7.5 |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 2,n=74,75,16,75,75,16 | -1.7 Millimeters of mercury | Standard Deviation 7.12 |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,4 hour,n=75,76,16,75,75,16 | -0.3 Millimeters of mercury | Standard Deviation 5.71 |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 4,n=73,75,16,75,75,16 | 5.3 Millimeters of mercury | Standard Deviation 6.11 |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 2,n=74,75,16,75,75,16 | -1.1 Millimeters of mercury | Standard Deviation 4.99 |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,4 hour,n=75,76,16,75,75,16 | 0.5 Millimeters of mercury | Standard Deviation 7.21 |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,4 hour,n=75,76,16,75,75,16 | 0.0 Millimeters of mercury | Standard Deviation 4.86 |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 3,n=74,75,16,75,75,16 | 3.4 Millimeters of mercury | Standard Deviation 5.76 |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 2,n=74,75,16,75,75,16 | 3.1 Millimeters of mercury | Standard Deviation 5.37 |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 2,n=74,75,16,75,75,16 | 1.9 Millimeters of mercury | Standard Deviation 8.06 |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,4 hour,n=75,76,16,75,75,16 | 1.0 Millimeters of mercury | Standard Deviation 7.28 |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 3,n=74,75,16,75,75,16 | 2.3 Millimeters of mercury | Standard Deviation 7.73 |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | SBP,Day 4,n=73,75,16,75,75,16 | 7.6 Millimeters of mercury | Standard Deviation 8.42 |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 | DBP,Day 4,n=73,75,16,75,75,16 | 8.3 Millimeters of mercury | Standard Deviation 6.94 |
Secondary
Clast of DTG and 3TC in in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Clast of DTG and 3TC in in the Fed State: Part 1 | DTG | 0.1060 Micrograms per milliliter |
| A: DTG 50 mg + EPIVIR 300 mg | Clast of DTG and 3TC in in the Fed State: Part 1 | 3TC | 0.0048 Micrograms per milliliter |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Clast of DTG and 3TC in in the Fed State: Part 1 | DTG | 0.1190 Micrograms per milliliter |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Clast of DTG and 3TC in in the Fed State: Part 1 | 3TC | 0.0066 Micrograms per milliliter |
Secondary
Clast of DTG and 3TC in in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Clast of DTG and 3TC in in the Fed State: Part 2 | DTG | 0.0975 Micrograms per milliliter |
| A: DTG 50 mg + EPIVIR 300 mg | Clast of DTG and 3TC in in the Fed State: Part 2 | 3TC | 0.0059 Micrograms per milliliter |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Clast of DTG and 3TC in in the Fed State: Part 2 | DTG | 0.1310 Micrograms per milliliter |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Clast of DTG and 3TC in in the Fed State: Part 2 | 3TC | 0.0091 Micrograms per milliliter |
Secondary
Clast of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Clast of DTG and 3TC in the Fasted State: Part 2 | DTG | 0.0800 Micrograms per milliliter | Geometric Coefficient of Variation 66.94 |
| A: DTG 50 mg + EPIVIR 300 mg | Clast of DTG and 3TC in the Fasted State: Part 2 | 3TC | 0.0069 Micrograms per milliliter | Geometric Coefficient of Variation 47.83 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Clast of DTG and 3TC in the Fasted State: Part 2 | DTG | 0.0862 Micrograms per milliliter | Geometric Coefficient of Variation 65.26 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Clast of DTG and 3TC in the Fasted State: Part 2 | 3TC | 0.0062 Micrograms per milliliter | Geometric Coefficient of Variation 41.6 |
90% CI: [0.9958, 1.167]
90% CI: [0.8474, 0.9663]
Secondary
CL/F of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | CL/F of DTG and 3TC in the Fasted State: Part 2 | DTG, n= 74, 74 | 1.0584 Liters per hour | Geometric Coefficient of Variation 40.29 |
| A: DTG 50 mg + EPIVIR 300 mg | CL/F of DTG and 3TC in the Fasted State: Part 2 | 3TC, n= 73, 74 | 23.4901 Liters per hour | Geometric Coefficient of Variation 18.63 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | CL/F of DTG and 3TC in the Fasted State: Part 2 | DTG, n= 74, 74 | 0.9164 Liters per hour | Geometric Coefficient of Variation 32.12 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | CL/F of DTG and 3TC in the Fasted State: Part 2 | 3TC, n= 73, 74 | 22.1200 Liters per hour | Geometric Coefficient of Variation 17.94 |
90% CI: [0.8021, 0.9347]
90% CI: [0.9207, 0.9604]
Secondary
CL/F of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | CL/F of DTG and 3TC in the Fed State: Part 1 | DTG | 0.8020 Liters per hour | Geometric Coefficient of Variation 32.34 |
| A: DTG 50 mg + EPIVIR 300 mg | CL/F of DTG and 3TC in the Fed State: Part 1 | 3TC | 22.3285 Liters per hour | Geometric Coefficient of Variation 21.02 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | CL/F of DTG and 3TC in the Fed State: Part 1 | DTG | 0.6947 Liters per hour | Geometric Coefficient of Variation 19.99 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | CL/F of DTG and 3TC in the Fed State: Part 1 | 3TC | 23.3159 Liters per hour | Geometric Coefficient of Variation 18.5 |
90% CI: [0.7658, 0.9796]
90% CI: [0.9951, 1.0957]
Secondary
CL/F of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | CL/F of DTG and 3TC in the Fed State: Part 2 | DTG | 0.8672 Liters per hour | Geometric Coefficient of Variation 35.93 |
| A: DTG 50 mg + EPIVIR 300 mg | CL/F of DTG and 3TC in the Fed State: Part 2 | 3TC | 20.4890 Liters per hour | Geometric Coefficient of Variation 18.5 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | CL/F of DTG and 3TC in the Fed State: Part 2 | DTG | 0.6542 Liters per hour | Geometric Coefficient of Variation 22.36 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | CL/F of DTG and 3TC in the Fed State: Part 2 | 3TC | 22.4815 Liters per hour | Geometric Coefficient of Variation 20.34 |
90% CI: [0.6736, 0.8448]
90% CI: [1.0424, 1.155]
Secondary
Cmax of Plasma DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Cmax of Plasma DTG and 3TC in the Fed State: Part 1 | DTG | 3.5068 Micrograms per milliliter | Geometric Coefficient of Variation 30.27 |
| A: DTG 50 mg + EPIVIR 300 mg | Cmax of Plasma DTG and 3TC in the Fed State: Part 1 | 3TC | 3.5413 Micrograms per milliliter | Geometric Coefficient of Variation 27.14 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Cmax of Plasma DTG and 3TC in the Fed State: Part 1 | DTG | 3.7900 Micrograms per milliliter | Geometric Coefficient of Variation 20.97 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Cmax of Plasma DTG and 3TC in the Fed State: Part 1 | 3TC | 2.5132 Micrograms per milliliter | Geometric Coefficient of Variation 18.74 |
90% CI: [0.9527, 1.2261]
90% CI: [0.6474, 0.7779]
Secondary
Cmax of Plasma DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Cmax of Plasma DTG and 3TC in the Fed State: Part 2 | DTG | 3.1015 Micrograms per milliliter | Geometric Coefficient of Variation 35.62 |
| A: DTG 50 mg + EPIVIR 300 mg | Cmax of Plasma DTG and 3TC in the Fed State: Part 2 | 3TC | 3.5824 Micrograms per milliliter | Geometric Coefficient of Variation 35.18 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Cmax of Plasma DTG and 3TC in the Fed State: Part 2 | DTG | 3.7516 Micrograms per milliliter | Geometric Coefficient of Variation 21.31 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Cmax of Plasma DTG and 3TC in the Fed State: Part 2 | 3TC | 2.4453 Micrograms per milliliter | Geometric Coefficient of Variation 33.88 |
90% CI: [0.5861, 0.795]
90% CI: [1.0521, 1.3908]
Secondary
Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1 | DTG | 0.6373 Micrograms per milliliter | Geometric Coefficient of Variation 40.18 |
| A: DTG 50 mg + EPIVIR 300 mg | Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 0.0331 Micrograms per milliliter | Geometric Coefficient of Variation 32.13 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1 | DTG | 0.8059 Micrograms per milliliter | Geometric Coefficient of Variation 32.77 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 0.0318 Micrograms per milliliter | Geometric Coefficient of Variation 31.81 |
90% CI: [1.1811, 1.3511]
90% CI: [0.9268, 0.9941]
Secondary
Lambda z of DTG and 3TC in in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed (represented by n= X,X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Lambda z of DTG and 3TC in in the Fasted State: Part 2 | DTG, n=74,74 | 0.0457 Per hour |
| A: DTG 50 mg + EPIVIR 300 mg | Lambda z of DTG and 3TC in in the Fasted State: Part 2 | 3TC, n= 73,74 | 0.0388 Per hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Lambda z of DTG and 3TC in in the Fasted State: Part 2 | DTG, n=74,74 | 0.0469 Per hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Lambda z of DTG and 3TC in in the Fasted State: Part 2 | 3TC, n= 73,74 | 0.0383 Per hour |
Secondary
Lambda z of DTG and 3TC in in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Lambda z of DTG and 3TC in in the Fed State: Part 1 | DTG | 0.0475 Per hour |
| A: DTG 50 mg + EPIVIR 300 mg | Lambda z of DTG and 3TC in in the Fed State: Part 1 | 3TC | 0.0378 Per hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Lambda z of DTG and 3TC in in the Fed State: Part 1 | DTG | 0.0475 Per hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Lambda z of DTG and 3TC in in the Fed State: Part 1 | 3TC | 0.0349 Per hour |
Secondary
Lambda z of DTG and 3TC in in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Lambda z of DTG and 3TC in in the Fed State: Part 2 | DTG | 0.0463 Per hour |
| A: DTG 50 mg + EPIVIR 300 mg | Lambda z of DTG and 3TC in in the Fed State: Part 2 | 3TC | 0.0403 Per hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Lambda z of DTG and 3TC in in the Fed State: Part 2 | DTG | 0.0457 Per hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Lambda z of DTG and 3TC in in the Fed State: Part 2 | 3TC | 0.0351 Per hour |
Secondary
Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1 | DTG | 0.0702 Micrograms per milliliter | Geometric Coefficient of Variation 58.85 |
| A: DTG 50 mg + EPIVIR 300 mg | Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 0.0056 Micrograms per milliliter | Geometric Coefficient of Variation 43.03 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1 | DTG | 0.0832 Micrograms per milliliter | Geometric Coefficient of Variation 56.42 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 0.0050 Micrograms per milliliter | Geometric Coefficient of Variation 37.58 |
90% CI: [1.0921, 1.2834]
90% CI: [0.834, 0.9443]
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE are presented.
Time frame: Up to Week 11
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | AEs | 14 Participants |
| A: DTG 50 mg + EPIVIR 300 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | SAEs | 0 Participants |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | AEs | 18 Participants |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | SAEs | 0 Participants |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | AEs | 1 Participants |
| Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | SAEs | 0 Participants |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | AEs | 15 Participants |
| Part 2- A: DTG 50 mg + EPIVIR 300 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | SAEs | 0 Participants |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | AEs | 12 Participants |
| Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | SAEs | 0 Participants |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | AEs | 1 Participants |
| Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 | SAEs | 0 Participants |
Secondary
Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1 | DTG | 3.3305 Percentage of AUC |
| A: DTG 50 mg + EPIVIR 300 mg | Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1 | 3TC | 0.8856 Percentage of AUC |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1 | DTG | 3.8870 Percentage of AUC |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1 | 3TC | 1.4830 Percentage of AUC |
Secondary
Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2 | DTG | 3.6835 Percentage of AUC |
| A: DTG 50 mg + EPIVIR 300 mg | Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2 | 3TC | 1.0443 Percentage of AUC |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2 | DTG | 3.8790 Percentage of AUC |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2 | 3TC | 1.7467 Percentage of AUC |
Secondary
Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1 | DTG | 3.4967 Percentage of AUC |
| A: DTG 50 mg + EPIVIR 300 mg | Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 1.0287 Percentage of AUC |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1 | DTG | 3.2582 Percentage of AUC |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 0.9052 Percentage of AUC |
Secondary
Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2 | DTG, n= 74,74 | 3.8923 Percentage of AUC |
| A: DTG 50 mg + EPIVIR 300 mg | Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2 | 3TC, n= 73,74 | 1.2518 Percentage of AUC |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2 | DTG, n= 74,74 | 3.5773 Percentage of AUC |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2 | 3TC, n= 73,74 | 1.1432 Percentage of AUC |
Secondary
t1/2 of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | t1/2 of DTG and 3TC in the Fasted State: Part 2 | DTG, n= 74,74 | 15.1538 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | t1/2 of DTG and 3TC in the Fasted State: Part 2 | 3TC, n= 73,74 | 17.8421 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | t1/2 of DTG and 3TC in the Fasted State: Part 2 | DTG, n= 74,74 | 14.7893 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | t1/2 of DTG and 3TC in the Fasted State: Part 2 | 3TC, n= 73,74 | 18.1071 Hour |
Secondary
T1/2 of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | T1/2 of DTG and 3TC in the Fed State: Part 1 | DTG | 14.5843 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | T1/2 of DTG and 3TC in the Fed State: Part 1 | 3TC | 18.3614 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | T1/2 of DTG and 3TC in the Fed State: Part 1 | DTG | 14.5816 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | T1/2 of DTG and 3TC in the Fed State: Part 1 | 3TC | 19.8579 Hour |
Secondary
T1/2 of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | T1/2 of DTG and 3TC in the Fed State: Part 2 | DTG | 14.9828 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | T1/2 of DTG and 3TC in the Fed State: Part 2 | 3TC | 17.2250 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | T1/2 of DTG and 3TC in the Fed State: Part 2 | DTG | 15.1718 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | T1/2 of DTG and 3TC in the Fed State: Part 2 | 3TC | 19.7311 Hour |
Secondary
Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1 | DTG | 72.0031 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 71.9289 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1 | DTG | 71.9303 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 71.9303 Hour |
Secondary
Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1 | DTG | 14.6917 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 17.0395 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1 | DTG | 14.7557 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 17.3436 Hour |
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1 | DTG | 2.0072 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 1.0047 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1 | DTG | 2.0017 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1 | 3TC | 1.0008 Hour |
90% CI: [-0.5, 0.248]
90% CI: [-0.253, -0.001]
Secondary
Tlag of DTG and 3TC in Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Tlag of DTG and 3TC in Fasted State: Part 2 | DTG | 0.0000 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | Tlag of DTG and 3TC in Fasted State: Part 2 | 3TC | 0.0000 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tlag of DTG and 3TC in Fasted State: Part 2 | DTG | 0.0000 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tlag of DTG and 3TC in Fasted State: Part 2 | 3TC | 0.0000 Hour |
90% CI: [-0.004, 0]
90% CI: [0, 0]
Secondary
Tlag of DTG and 3TC in Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Tlag of DTG and 3TC in Fed State: Part 1 | DTG | 0.0000 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | Tlag of DTG and 3TC in Fed State: Part 1 | 3TC | 0.0000 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tlag of DTG and 3TC in Fed State: Part 1 | DTG | 0.2522 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tlag of DTG and 3TC in Fed State: Part 1 | 3TC | 0.0000 Hour |
90% CI: [0.25, 0.378]
90% CI: [0, 0.127]
Secondary
Tlag of DTG and 3TC in Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Tlag of DTG and 3TC in Fed State: Part 2 | DTG | 0.0000 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | Tlag of DTG and 3TC in Fed State: Part 2 | 3TC | 0.0000 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tlag of DTG and 3TC in Fed State: Part 2 | 3TC | 0.0000 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tlag of DTG and 3TC in Fed State: Part 2 | DTG | 0.1253 Hour |
90% CI: [0, 0.25]
90% CI: [0, 0.125]
Secondary
Tlast of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Tlast of DTG and 3TC in the Fasted State: Part 2 | DTG | 71.6813 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | Tlast of DTG and 3TC in the Fasted State: Part 2 | 3TC | 71.7138 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tlast of DTG and 3TC in the Fasted State: Part 2 | DTG | 71.8243 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tlast of DTG and 3TC in the Fasted State: Part 2 | 3TC | 71.8153 Hour |
Secondary
Tlast of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Tlast of DTG and 3TC in the Fed State: Part 1 | DTG | 71.8265 Hours |
| A: DTG 50 mg + EPIVIR 300 mg | Tlast of DTG and 3TC in the Fed State: Part 1 | 3TC | 71.8265 Hours |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tlast of DTG and 3TC in the Fed State: Part 1 | 3TC | 71.9758 Hours |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tlast of DTG and 3TC in the Fed State: Part 1 | DTG | 71.9758 Hours |
Secondary
Tlast of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Tlast of DTG and 3TC in the Fed State: Part 2 | DTG | 72.0292 Hours |
| A: DTG 50 mg + EPIVIR 300 mg | Tlast of DTG and 3TC in the Fed State: Part 2 | 3TC | 72.0292 Hours |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tlast of DTG and 3TC in the Fed State: Part 2 | DTG | 71.8711 Hours |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tlast of DTG and 3TC in the Fed State: Part 2 | 3TC | 71.8711 Hours |
Secondary
Tmax of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Tmax of DTG and 3TC in the Fasted State: Part 2 | DTG | 2.5008 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | Tmax of DTG and 3TC in the Fasted State: Part 2 | 3TC | 1.0063 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tmax of DTG and 3TC in the Fasted State: Part 2 | DTG | 2.5004 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tmax of DTG and 3TC in the Fasted State: Part 2 | 3TC | 1.0011 Hour |
90% CI: [-0.497, 0.132]
90% CI: [-0.376, -0.001]
Secondary
Tmax of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Tmax of DTG and 3TC in the Fed State: Part 1 | DTG | 1.5013 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | Tmax of DTG and 3TC in the Fed State: Part 1 | 3TC | 1.0001 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tmax of DTG and 3TC in the Fed State: Part 1 | DTG | 5.0006 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tmax of DTG and 3TC in the Fed State: Part 1 | 3TC | 3.5003 Hour |
90% CI: [1.872, 4.496]
90% CI: [1.5, 2.751]
Secondary
Tmax of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Tmax of DTG and 3TC in the Fed State: Part 2 | DTG | 1.5007 Hour |
| A: DTG 50 mg + EPIVIR 300 mg | Tmax of DTG and 3TC in the Fed State: Part 2 | 3TC | 1.0003 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tmax of DTG and 3TC in the Fed State: Part 2 | DTG | 5.0019 Hour |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Tmax of DTG and 3TC in the Fed State: Part 2 | 3TC | 2.7508 Hour |
90% CI: [1.748, 3.751]
90% CI: [0.998, 2.252]
Secondary
Vz/F of DTG and 3TC in the Fasted State: Part 2
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Vz/F of DTG and 3TC in the Fasted State: Part 2 | DTG, n= 74, 74 | 23.1159 Liters | Geometric Coefficient of Variation 37.18 |
| A: DTG 50 mg + EPIVIR 300 mg | Vz/F of DTG and 3TC in the Fasted State: Part 2 | 3TC, n= 73, 74 | 650.7952 Liters | Geometric Coefficient of Variation 35.55 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Vz/F of DTG and 3TC in the Fasted State: Part 2 | DTG, n= 74, 74 | 19.8124 Liters | Geometric Coefficient of Variation 32.73 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Vz/F of DTG and 3TC in the Fasted State: Part 2 | 3TC, n= 73, 74 | 599.5525 Liters | Geometric Coefficient of Variation 34.28 |
90% CI: [0.7914, 0.9282]
90% CI: [0.8613, 0.9728]
Secondary
Vz/F of DTG and 3TC in the Fed State: Part 1
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Vz/F of DTG and 3TC in the Fed State: Part 1 | DTG | 16.7520 Liters | Geometric Coefficient of Variation 28.45 |
| A: DTG 50 mg + EPIVIR 300 mg | Vz/F of DTG and 3TC in the Fed State: Part 1 | 3TC | 593.2054 Liters | Geometric Coefficient of Variation 29.23 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Vz/F of DTG and 3TC in the Fed State: Part 1 | DTG | 14.4964 Liters | Geometric Coefficient of Variation 15.87 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Vz/F of DTG and 3TC in the Fed State: Part 1 | 3TC | 643.0977 Liters | Geometric Coefficient of Variation 41.08 |
90% CI: [0.7629, 0.9816]
90% CI: [0.9139, 1.286]
Secondary
Vz/F of DTG and 3TC in the Fed State: Part 2
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Population: PK Parameter FD Summary Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| A: DTG 50 mg + EPIVIR 300 mg | Vz/F of DTG and 3TC in the Fed State: Part 2 | DTG | 19.0954 Liters | Geometric Coefficient of Variation 36.45 |
| A: DTG 50 mg + EPIVIR 300 mg | Vz/F of DTG and 3TC in the Fed State: Part 2 | 3TC | 535.8125 Liters | Geometric Coefficient of Variation 35.63 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Vz/F of DTG and 3TC in the Fed State: Part 2 | DTG | 14.6215 Liters | Geometric Coefficient of Variation 11.63 |
| B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Vz/F of DTG and 3TC in the Fed State: Part 2 | 3TC | 641.3744 Liters | Geometric Coefficient of Variation 32.1 |
90% CI: [0.6702, 0.8749]
90% CI: [1.0869, 1.3182]