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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

2019-09-18 03:27:46 | BioPortfolio

Summary

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.

Study Design

Conditions

Healthy

Intervention

Bedaquiline (Test formulation), Bedaquiline (Reference formulation)

Location

SGS Life Science Services
Antwerpen
Belgium
2060

Status

Not yet recruiting

Source

Janssen Research & Development, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-18T03:27:46-0400

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