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A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions

NCT01619527 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2013-03-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under fed and fasted conditions) in healthy participants.

Conditions

  • Healthy Participants

Interventions

DRUG

darunavir

Type=exact number, unit=mg, number=400, form=tablet, route=oral. Two tablets as a single dose or a tablet in combination with cobicistat

DRUG

cobicistat

Type=exact number, unit=mg, number=150, form=tablet, route=oral. One tablet as a single dose or a tablet in combination with darunavir

Sponsors & Collaborators

  • Janssen R&D Ireland

    lead INDUSTRY

Principal Investigators

  • Janssen R&D Ireland Clinical Trial · Janssen R&D Ireland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01619527 on ClinicalTrials.gov