Clinical trial NCT00622141: Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir®
Official title: Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir® in Thai Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: bioequivalence
ritonavir boosted generic GPO saquinavir
saftey
pharmacokinetics
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: The Government Pharmaceutical Organization
First posted: 2008-02-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility 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

Primary outcomes:
measure: To establish bioequivalence of ritonavir boosted generic GPO saquinavir generic, with Invirase® and Norvir® as reference drug.
timeFrame: 8 days
Secondary outcomes:
measure: The secondary objective is to evaluate the short-term tolerability and safety profiles of generic saquinavir in healthy male volunteers.
timeFrame: 8 days
Other outcomes:
Locations:
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
name: Kiat Ruxrungtham, MD
role: PRINCIPAL_INVESTIGATOR
References: