Dataset from An Open-label Single-Center, 4-Period William's Cross-Over Design Drug Interaction Trial to Determine the Effects of Sorbitol-Containing Solutions on Lamivudine Exposure Following Administration of Lamivudine Oral Solution in Healthy Adult Subjects

Lamivudine (3TC) is a nucleoside analogue indicated in combination with other antiretroviral
agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults
and children. Documented literature elucidates that simultaneous administration of multiple
sorbitol-containing products could increase the potential for a significant interaction and
may contribute to the lower 3TC exposures.

In this study several sorbitol doses (3.2 gram (g), 10.2 g, and 13.4 g solutions) will be
administered with lamivudine to investigate dose dependency and mimic the situation where
multiple sorbitol-containing antiretroviral medications may be co-administered with
lamivudine. It will be open label, randomized, 4-way crossover (by William's design method)
design at a single centre. Randomized participants will receive a single dose of each of four
treatments after wash out period of minimum 7 days.