Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir®

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The previous two studies of generic GPO saquinavir failed to prove bioequivalence. In this study the bio-equivalence will be investigated in healthy Thai volunteers, to see whether the generic GPO saquinavir shows bioequivalence when boosted with Norvir®. If the generic formulation is bioequivalent subsequent studies may follow in HIV-1 positive patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborator: The Government Pharmaceutical Organization
• Treatments: Ritonavir; Saquinavir

Criteria

Inclusion Criteria:

• Written informed consent

• Healthy male 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

• 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