Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®
This study has been completed.
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborator:
The Government Pharmaceutical Organization
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00477126
First received: May 20, 2007
Last updated: April 3, 2012
Last verified: April 2012
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Purpose
To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: GPO ritonavir versus Norvir |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Bioequivalence Study of Generic GPO Ritonavir Versus Norvir® in Thai Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:
Primary Outcome Measures:
- Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate the short-term tolerability and safety profiles of generic ritonavir in healthy male and female volunteers. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Active Comparator: 1
start generic product cross over to reference product
|
Drug: GPO ritonavir versus Norvir
RTV generic compared to reference drugs (Norvir, Abbott)
|
|
Active Comparator: 2
start reference product cross over to generic product
|
Drug: GPO ritonavir versus Norvir
RTV generic compared to reference drugs (Norvir, Abbott)
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Written informed consent
- Healthy male or female 18-45 years old
- Documented negative test for HIV-1 infection < 1 wk prior to start of study and with no risk of
- HIV exposure in the last 6 months
- For female subjects: documented negative pregnancy test <3 wk prior to start of study, not breastfeeding
- BMI 18-25
- Normal physical examination
- Normal CBC, BUN, Cr, AST, ALT, Total bilirubin, no evidence of active or chronic HBV or HCV Infection
Exclusion Criteria:
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the study.
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- Inability to understand the nature and extent of the study and the procedures required.
- Participation in a drug study within 60 days prior to the first dose.
- Febrile illness within 3 days before the first dose.
- Use of concomitant medication
- Smoke cigarettes not more than 10 cigarettes a day.
- Drink alcohol not more than 2 units a day
- Discontinue smoking and alcohol for at least 1 month before enrollment.
- Take other medication regularly
- Involvement in any drug addiction
- Heart disease, hypertension, liver disease, kidney disease, GI disease, allergic disease or other diseases which may interfere with the PK of study drugs
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477126
Locations
| Thailand | |
| The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | |
| Bangkok, Thailand, 10330 | |
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
The Government Pharmaceutical Organization
Investigators
| Principal Investigator: | Kiat Ruxrungtham, MD | The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kiat Ruxrungtham, HIV-NAT |
| ClinicalTrials.gov Identifier: | NCT00477126 History of Changes |
| Other Study ID Numbers: | HIV-NAT 037 |
| Study First Received: | May 20, 2007 |
| Last Updated: | April 3, 2012 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
|
ritonavir generic capsule Norvir® Thailand Determine bioequivalence between Norvir and GPO ritonavir |
Additional relevant MeSH terms:
|
Ritonavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013