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NCT01519336 · ClinicalTrials.gov registry record · Phase 1
A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01519336 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 40 participants.
The verdict
NCT01519336, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG ritonavir
- DRUG darunavir
- DRUG danoprevir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01519336
The ClinicalTrials.gov registry entry for NCT01519336 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which ritonavir is the first listed.
NCT01519336 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01519336 about?
NCT01519336 is a clinical study titled "A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers". 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 danop...
What is the current status of trial NCT01519336?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-02. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01519336?
The interventions under investigation include: ritonavir (DRUG), darunavir (DRUG), danoprevir (DRUG).
Who is sponsoring clinical trial NCT01519336?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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