Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects in the Fasting and Fed State
Status:
Recruiting
Trial end date:
2022-01-31
Target enrollment:
Participant gender:
Summary
The primary purpose of this study is to evaluate the bioequivalence of two dotilavir sodium
tablets in the fasting and fed state. The secondary purpose of this study is to observe the
safety of the test and reference preparations. An open-label, randomized, single-dose,
crossover study in healthy Chinese volunteers was performed. A single oral dose of 50 mg of
two dotilavir sodium tablets was administered to 64 healthy volunteers, with 36 in the fasted
group and 28 consuming a high-fat diet. The evaluated pharmacokinetic parameters, including
maximum concentration (Cmax), the area under the concentration-time curve (AUC0-t and AUC0-∞)
were assessed for bioequivalence.