Dataset from A 2-Part, Phase I, Single Dose, Crossover Relative Bioavailability Study of Both TIVICAY 10 mg Conventional Tablets and 5 mg Dispersible Tablets Compared to Conventional TIVICAY Tablets in Fasted Healthy Adult Subjects

The aim of this cross-over study is to compare the relative bioavailability and
pharmacokinetic parameters of both 10 mg conventional tablets and 5 mg dispersible tablets of
dolutegravir (DTG) with that of 25 mg or 50 mg conventional DTG tablets. The study will be
carried out in 2 parts. Part 1 of the study will be open-label, 2 period designs with a wash
out period of at least 7 days between the dosing periods. Subjects will be randomized to
receive either single dose of five 10 mg DTG tablets or one 50 mg DTG tablet in a crossover
manner in the fasting state. Part 2 of the study will be a 3 period crossover design with a
wash out period of at least 7 days between the dosing periods. Subjects will be randomized to
receive either single dose of five 5 mg DTG tablets (administered as dispersed with water or
directly to mouth) or one 25 mg DTG tablet in a crossover manner in the fasting state.
Subjects will have a follow-up visit 7-10 days post last dose of study treatment.
Approximately 14 healthy subjects will participate in Part 1 and approximately 24 healthy
subjects will participate in Part 2 of the study. The total duration of Part 1 will be
approximately 7 to 8 weeks and that of part 2 will be approximately 8 to 9 weeks.

TIVICAY® is a trademark of the GlaxoSmithKline group of companies.