Dataset from An Open-label, Randomized, Single Dose, Crossover, Pivotal Bioequivalence Study of Fixed-dose Combination Tablets of Dolutegravir and Lamivudine Versus Dolutegravir and Lamivudine Single Entities and Food Effect Assessment in Healthy Volunteers

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.