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NCT01392755 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01392755 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 32 participants.
The verdict
NCT01392755, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study 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.
Interventions
- DRUG ritonavir
- DRUG omeprazole
- DRUG danoprevir
- DRUG ranitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-07 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01392755
The ClinicalTrials.gov registry entry for NCT01392755 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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 4 interventions - of which ritonavir is the first listed.
NCT01392755 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01392755 about?
NCT01392755 is a clinical study titled "A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers". 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 ...
What is the current status of trial NCT01392755?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-07. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01392755?
The interventions under investigation include: ritonavir (DRUG), omeprazole (DRUG), danoprevir (DRUG), ranitidine (DRUG).
Who is sponsoring clinical trial NCT01392755?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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