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

The HIV Netherlands Australia Thailand Research Collaboration

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

HIV Infections

Treatments

Drug: generic GPO saquinavir and novir vs invirase and norvir

Study type

Interventional

Funder types

Other

Identifiers

NCT00622141

HIV-NAT 038

Details and patient eligibility

About

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.

Full description

The primary objective is to establish bioequivalence of "ritonavir boosted generic GPO saquinavir", with Invirase® and Norvir® as the reference drug.

The secondary objective is to evaluate the short-term tolerability and safety profiles of generic saquinavir in healthy male volunteers.

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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