Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GPO ritonavir versus Norvir

• Registration Number: NCT00477126
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

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 Timeline

• Study Start: 2007-01
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Study First Submitted: 2007-05-20
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-03
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	GPO ritonavir versus Norvir	start generic product cross over to reference product
2	GPO ritonavir versus Norvir	start reference product cross over to generic product

Primary Outcome Measures

Name	Time	Method
Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug.	2 months

Secondary Outcome Measures

Name	Time	Method
Evaluate the short-term tolerability and safety profiles of generic ritonavir in healthy male and female volunteers.	2 months

Trial Locations

Locations (1)

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT); 🇹🇭 Bangkok, Thailand