Bioavailability Study of 10 Milligram (mg) and 5 mg Tablets Versus Conventional Tablets of Dolutegravir

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

May 3, 2017

Primary Completion Date

June 23, 2017

Study Completion Date

June 23, 2017

Conditions
HIV Infections
Interventions
DRUG

Conventional dolutegravir 10 mg tablet

Single dose of five 10 mg DTG tablets will be administered directly to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 1. DTG will be a white, round shaped, biconvex tablet.

DRUG

Conventional dolutegravir 50 mg tablet

Single dose of one 50 mg tablet will be administered directly to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 1. DTG will be a white, round shaped, biconvex tablet.

DRUG

Dispersible dolutegravir 5 mg tablet

Single dose of five 5 mg DTG tablets will be administered as dispersed in water or direct to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 2. DTG will be a white, round shaped, biconvex tablet.

DRUG

Conventional dolutegravir 25 mg tablet

Single dose of one 25 mg DTG tablet will be administered directly to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 2. DTG will be a white, round shaped, biconvex tablet.

Trial Locations (1)

78744

GSK Investigational Site, Austin

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

ViiV Healthcare

INDUSTRY