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Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

NCT00477126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2012-04-05

No results posted yet for this study

Summary

To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.

Conditions

  • Healthy

Interventions

DRUG

GPO ritonavir versus Norvir

RTV generic compared to reference drugs (Norvir, Abbott)

Sponsors & Collaborators

  • The Government Pharmaceutical Organization

    collaborator OTHER_GOV

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Kiat Ruxrungtham, MD · The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • Thailand

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 NCT00477126 on ClinicalTrials.gov