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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This study has been withdrawn prior to enrollment.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: March 24, 2015
Last verified: March 2015
February 12, 2008
March 24, 2015
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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 ]
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 ]
Same as current
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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
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
0
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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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Thailand
 
NCT00622141
HIV-NAT 038
No
Not Provided
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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
March 2015

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