Dataset from A Phase I, Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Lamivudine in Healthy Subjects

Dolutegravir (DTG) and lamivudine (3TC) are indicated in combination with other
antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1)
infection. Fixed dose combination (FDC) tablets of existing approved drugs are preferred by
many patients and offer the potential for increased patient adherence and consequently a
reduced likelihood of virological failure and viral resistance.

The purpose of the present study is to evaluate the relative bioavailability of two
experimental FDC tablets of DTG and 3TC relative to co-administration of the single entity
products in healthy adult subjects.

This study will be conducted as a randomized, open label three-way, crossover design with 6
treatment sequences in approximately 30 subjects. Each subject will have a screening visit
within 30 days prior to the first dose of study drug, three treatment periods each with a
single dose of study drug and a follow-up visit within 7-14 days after the last dose of study
drug. There will be at least 7 days washout between dosing periods. The total duration of
participation of a subject in this study will be approximately 9 weeks.