drugset / Trial / NCT01392755

A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers

NCT01392755

Phase 1 Completed 32 enrolled Hoffmann-La Roche
RandomizedSingle-groupOpen-labelTreatment

Summary

This randomized, open-label study will evaluate the effect of food, and the effect of omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.

Timeline

Start
2011-07
Primary completion
2011-09
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Omeprazole Other / unclassified Oral
Subject Ranitidine Unknown Oral
Subject danoprevir Small molecule Oral
Background Ritonavir Other / unclassified Oral

Indications

No indication recorded.