Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir®
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration