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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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01392755 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01392755 record still lists
NCT01392755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which ritonavir is the first listed.
NCT01392755 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01392755's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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