Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration (Other)

Overall Status

Completed

CT.gov ID

NCT00477126

Collaborator

The Government Pharmaceutical Organization (Other)

Enrollment

Location

Arms

Duration (Months)

15.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: GPO ritonavir versus Norvir	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug. [2 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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