Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

The HIV Netherlands Australia Thailand Research Collaboration

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GPO ritonavir versus Norvir

Study type: Interventional

Funder types: Other

Identifiers

NCT00477126

HIV-NAT 037

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups

1

Active Comparator group

Description:

start generic product cross over to reference product

Treatment:

Drug: GPO ritonavir versus Norvir

2

Active Comparator group

Description:

start reference product cross over to generic product

Treatment:

Drug: GPO ritonavir versus Norvir