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Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects

Global Alliance for TB Drug Development · 2007
ClinicalTrials.gov · Datasets · License: Public Domain · 2007
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bioavailabilitytuberculosis
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.
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