Completed PHASE1 INTERVENTIONAL 2-arm NCT01308658

TMC114-TiDP3-C176 - A Study in Healthy Volunteers Investigating the Bioequivalence Between Two Commercially Available 400-mg Tablets to One New 800-mg Tablet of Darunavir (DRV) in the Presence of Low-dose Ritonavir Under Fed and Fasted Conditions

A Phase I, Open-label, Randomized, 2-panel, 2-way Crossover Pivotal Bioequivalence Trial Between the Commercially Available 400-mg Tablet Formulation (F030) and the 800-mg Tablet Formulation of Darunavir (G002), in the Presence of Low-dose Ritonavir Under Fasted and Fed Conditions

Sponsor: Tibotec Pharmaceuticals, Ireland

Conditions Healthy

Interventions Darunavir (DRV) ritonavir

Updated 5 times since 2017 Last updated: Feb 5, 2014 Started: Jan 31, 2011 Completion: May 31, 2011

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 Healthy, this trial is completed. The trial is conducted by Tibotec Pharmaceuticals, Ireland and has accumulated 5 data snapshots since 2011. 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

Jan 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Tibotec Pharmaceuticals, Ireland

Data source: Tibotec Pharmaceuticals, Ireland

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

Study Locations

• Berlin, Germany