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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 20, 2007

Last Updated Date

April 3, 2012

Start Date ^ICMJE

January 2007

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug.

Change History

Complete list of historical versions of study NCT00477126 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Evaluate the short-term tolerability and safety profiles of generic ritonavir in healthy male and female volunteers.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

Official Title ^ICMJE

Bioequivalence Study of Generic GPO Ritonavir Versus Norvir® in Thai Healthy Volunteers

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: GPO ritonavir versus Norvir

RTV generic compared to reference drugs (Norvir, Abbott)

Study Arm (s)

Active Comparator: 1
start generic product cross over to reference product

Intervention: Drug: GPO ritonavir versus Norvir
Active Comparator: 2
start reference product cross over to generic product

Intervention: Drug: GPO ritonavir versus Norvir

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2007

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT00477126

Other Study ID Numbers ^ICMJE

HIV-NAT 037

Has Data Monitoring Committee

Yes

Responsible Party

Kiat Ruxrungtham, HIV-NAT

Study Sponsor ^ICMJE

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators ^ICMJE

The Government Pharmaceutical Organization

Investigators ^ICMJE

Principal Investigator:

Kiat Ruxrungtham, MD

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

Information Provided By

The HIV Netherlands Australia Thailand Research Collaboration

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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