NCT00622141

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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

Timeline

• First posted: 2008-02-22
• Last updated: 2015-03-26