Status:
WITHDRAWN
Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir®
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
The Government Pharmaceutical Organization
Conditions:
HIV Infections
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
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 saq...
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00622141
Last Update
March 26 2015
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