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Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014