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Sponsors and Collaborators: |
The HIV Netherlands Australia Thailand Research Collaboration Government Pharmaceutical Organization (GPO) |
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Information provided by: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT00477126 |
To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: GPO ritonavir versus Norvir |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | Bioequivalence Study of Generic GPO Ritonavir Versus Norvir® in Thai Healthy Volunteers |
Enrollment: | 16 |
Study Start Date: | January 2007 |
Study Completion Date: | February 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
start generic product cross over to reference product
|
Drug: GPO ritonavir versus Norvir
RTV generic compared to reference drugs (Norvir, Abbott)
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2: Active Comparator
start reference product cross over to generic product
|
Drug: GPO ritonavir versus Norvir
RTV generic compared to reference drugs (Norvir, Abbott)
|
This study will be performed to evaluate if the new generic GPO ritonavir product is bio-equivalent to Norvir and to compare the short-term tolerability and safety profiles.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Thailand | |
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | |
Bangkok, Thailand, 10330 |
Principal Investigator: | Kiat Ruxrungtham, MD | The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) |
Responsible Party: | HIV-NAT ( Kiat Ruxrungtham ) |
Study ID Numbers: | HIV-NAT 037 |
Study First Received: | May 20, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00477126 |
Health Authority: | Thailand: Ethical Committee |
ritonavir generic capsule Norvir® Thailand Determine bioequivalence between Norvir and GPO ritonavir |
Ritonavir Healthy |
Anti-Infective Agents HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Protease Inhibitors |