A Phase I, Two-Panel, Open-Label, Randomized, 3-way Crossover Trial in Healthy Subjects to Determine the Relative Oral Bioavailability of TMC207 After Single Dose Administration of TMC207 100 mg as the Phase II Clinical Trial Tablet Formulation and as a Newly Developed Tablet Formulation, Under Fed and Fasted Conditions

Trial Profile

A Phase I, Two-Panel, Open-Label, Randomized, 3-way Crossover Trial in Healthy Subjects to Determine the Relative Oral Bioavailability of TMC207 After Single Dose Administration of TMC207 100 mg as the Phase II Clinical Trial Tablet Formulation and as a Newly Developed Tablet Formulation, Under Fed and Fasted Conditions

Completed
Phase of Trial: Phase I

Latest Information Update: 18 Mar 2013

At a glance

  • Drugs Bedaquiline (Primary)
  • Indications Tuberculosis
  • Focus Pharmacokinetics
  • Sponsors Janssen Research & Development; Tibotec-Virco Group
  • Most Recent Events

    • 18 Mar 2013 Primary endpoints added as reported by ClinicalTrials.gov.
    • 18 Mar 2013 Additional lead trial centre deleted as reported by ClinicalTrials.gov record.
    • 01 Jun 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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