Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir®
Phase 1
Withdrawn
- Conditions
- HIV Infections
- Interventions
- Drug: generic GPO saquinavir and novir vs invirase and norvir
- Registration Number
- NCT00622141
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A generic GPO saquinavir and novir vs invirase and norvir Day 1: receive a single dose of Invirase®/Norvir® 1,000 mg / 100mg 7-day washout period will follow. Day 8: take generic GPO squinavir/Norvir B generic GPO saquinavir and novir vs invirase and norvir Day 1: take generic GPO squinavir/Norvir 7-day washout period will follow. Day 8: receive a single dose of Invirase®/Norvir® 1,000 mg / 100mg
- Primary Outcome Measures
Name Time Method To establish bioequivalence of ritonavir boosted generic GPO saquinavir generic, with Invirase® and Norvir® as reference drug. 8 days
- Secondary Outcome Measures
Name Time Method The secondary objective is to evaluate the short-term tolerability and safety profiles of generic saquinavir in healthy male volunteers. 8 days