A Phase 1 interventional study of danoprevir and darunavir in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 1 and Interventional
This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential drug-drug interactions between darunavir and danoprevir when administered together with low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive either darunavir or danoprevir together with low-dose ritonavir for 10 days. In Period 2, all subjects will receive darunavir plus danoprevir together with ritonavir for 10 days. Anticipated time on study treatment is 20 days.
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: danoprevir · Drug: ritonavir
Drug: darunavir · Drug: ritonavir
Drug: danoprevir · Drug: darunavir · Drug: ritonavir
100 mg q12h
600 mg q12h
100 mg q12h
Effect of coadministration of darunavir (DRV), danoprevir (DNV) and ritonavir (RTV) on DRV/DNV/RTV pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: approximately 2 months
Safety: Incidence of adverse events
Time frame: approximately 2 months
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche