Bioequivalence Study of Generic GPO Ritonavir Versus Norvir® - Full Text View

Sponsors and Collaborators:	The HIV Netherlands Australia Thailand Research Collaboration Government Pharmaceutical Organization (GPO)
Information provided by:	The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:	NCT00477126

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: GPO ritonavir versus Norvir	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir

U.S. FDA Resources

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

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
1: Active Comparator start generic product cross over to reference product	Drug: GPO ritonavir versus Norvir RTV generic compared to reference drugs (Norvir, Abbott)
2: Active Comparator 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

Government Pharmaceutical Organization (GPO)

Investigators

Principal Investigator:

Kiat Ruxrungtham, MD

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

More Information

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) This link exits the ClinicalTrials.gov site

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

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:

ritonavir generic capsule
Norvir®
Thailand
Determine bioequivalence between Norvir and GPO ritonavir

Study placed in the following topic categories:

Ritonavir
Healthy

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009