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

NCT00622141 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2015-03-26

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

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

Sponsors & Collaborators

  • The Government Pharmaceutical Organization

    collaborator OTHER_GOV

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Kiat Ruxrungtham, MD · The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00622141 on ClinicalTrials.gov