Completed PHASE1 INTERVENTIONAL 6-arm NCT01803373

A Study to Assess the Relative Bioavailability of TMC207 Following Single-Dose Administrations of Two Pediatric Formulations in Healthy Adult Participants

A Phase I, Open-label, Randomized, 3-way Crossover Study in 3 Panels of Healthy, Adult Subjects to Assess the Relative Bioavailability of TMC207 Following Single-dose Administration of Two Pediatric Formulations Using a 100 mg Tablet Formulation as the Reference, With and Without Food.

Sponsor: Janssen Infectious Diseases BVBA

Conditions Biological Availability Healthy

Interventions Treatment A (reference) Treatment B Treatment C

Updated 5 times since 2017 Last updated: Mar 16, 2014 Started: Apr 30, 2013 Primary completion: Aug 31, 2013 Completion: Aug 31, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Biological Availability and Healthy, this trial is completed. The trial is conducted by Janssen Infectious Diseases BVBA and has accumulated 5 data snapshots since 2013. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Apr 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Janssen Infectious Diseases BVBA

Data source: Janssen Infectious Diseases BVBA

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Groningen, Netherlands