Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects
Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1, single-center, randomized, balanced, single-dose, two-treatment,
two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the
pharmacokinetics of PA-824. This study was designed to understand the possible effects of a
high-calorie, high-fat meal on PA-824 absorption and pharmacokinetics. The hypothesis to be
tested in this study is that the rate and extent of absorption of PA-824, as measured by
Tmax, Cmax, AUC(0-t), and AUC(0 inf), are the same after a high-calorie, high-fat meal as
compared with after a minimum 10-hour fast.