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

This study has been withdrawn prior to enrollment.
(The study was never started because the sponsor decided not to manufacture the investigational product.)
Sponsor:
Collaborator:
The Government Pharmaceutical Organization
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00622141
First received: February 12, 2008
Last updated: June 30, 2011
Last verified: June 2011

February 12, 2008
June 30, 2011
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To establish bioequivalence of ritonavir boosted generic GPO saquinavir generic, with Invirase® and Norvir® as reference drug. [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00622141 on ClinicalTrials.gov Archive Site
The secondary objective is to evaluate the short-term tolerability and safety profiles of generic saquinavir in healthy male volunteers. [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
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Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir®
Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir® in Thai Healthy Volunteers

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
HIV Infections
Drug: generic GPO saquinavir and novir vs invirase and norvir
Norvir® 100mg capsules, Invirase® 1,000 mg capsules Generic GPO Saquinavir 1,000 mg capsules For phase 1 and 2 - At day 1 subjects of group A will receive a single dose of Invirase®/Norvir® 1,000 mg / 100mg, while group B will receive generic GPO saquinavir / Norvir® 1,000 mg / 100mg as single dose. The same day the first 24 hr PK curve will be done. After this, a 7-day washout period will follow. At day 8 group A will take generic GPO saquinavir / Norvir® and Group B will take Invirase®/Norvir®. At this day, the second 24 hr PK curve will be done
  • Active Comparator: A
    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
    Intervention: Drug: generic GPO saquinavir and novir vs invirase and norvir
  • Active Comparator: B
    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
    Intervention: Drug: generic GPO saquinavir and novir vs invirase and norvir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
30
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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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00622141
HIV-NAT 038
No
Professor Kiat Ruxrungtham, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
The Government Pharmaceutical Organization
Principal Investigator: Kiat Ruxrungtham, MD The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
The HIV Netherlands Australia Thailand Research Collaboration
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP