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TMC114-TiDP29-C169: Bioavailability and Pharmacokinetics Trial Comparing Darunavir Pediatric Suspension Formulation to Current Darunavir Tablet

NCT00752310 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2011-06-09

No results posted yet for this study

Summary

The purpose of this study is to evaluate in healthy volunteers how much and how fast the new suspension compared to the commercial darunavir tablet, given in combination with low-dose ritonavir, are absorbed into the body (called the relative oral bioavailability).

Conditions

  • Pharmacokinetics

Interventions

DRUG

Darunavir

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals Limited Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-08-31
Completion
2008-08-31

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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 NCT00752310 on ClinicalTrials.gov