Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

start generic product cross over to reference product

Group Type ACTIVE_COMPARATOR

GPO ritonavir versus Norvir

Intervention Type DRUG

RTV generic compared to reference drugs (Norvir, Abbott)

2

start reference product cross over to generic product

Group Type ACTIVE_COMPARATOR

GPO ritonavir versus Norvir

Intervention Type DRUG

RTV generic compared to reference drugs (Norvir, Abbott)

Interventions

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GPO ritonavir versus Norvir

RTV generic compared to reference drugs (Norvir, Abbott)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes