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A Study of Bedaquiline 100 Milligram (mg) Tablets Administered as Different Test Formulations Compared to the Commercial Tablet Formulation (F001) in Healthy Adult Participants

Janssen Research & Development, LLC · 2019
ClinicalTrials.gov · Datasets · License: Public Domain · 2019
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The purpose of this study is to assess the rate and extent of absorption of bedaquiline following administration of a single oral dose of 100 milligram (mg) equivalent (1\*100 mg) given as different test tablet formulations compared to the administration of a single oral dose of 100 mg equivalent (1\*100 mg) formulated as SIRTURO commercial tablet (formulation F001), under fasted conditions in healthy adult participants. Also, to assess the effect of a standardized breakfast on the rate and extent of absorption of bedaquiline compared to fasted conditions following administration of a single oral dose of 100 mg equivalent (1\*100 mg) for each of the different test tablet formulations.
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