drugset / Trial / NCT01483729

A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers

NCT01483729

Phase 1 Completed 36 enrolled Hoffmann-La Roche
RandomizedCrossoverOpen-labelTreatment

Summary

This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In Part 1, subjects will be randomized to receive single oral doses of one of three tablet formulations of danoprevir plus the reference ritonavir formulation, with an at least 7-day washout between periods. In Part 2, subjects will be randomized to receive single oral doses of one of three tablet formulations of ritonavir plus the reference formulation of danoprevir, with at least a 7-day washout betwen periods. The anticipated time on study is up to 30 days.

Timeline

Start
2011-12
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ritonavir Other / unclassified Oral
Subject danoprevir Small molecule Oral

Indications

No indication recorded.