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NCT01319266 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Renal Function and Subjects With Varying Degrees of Renal Impairment
A Phase 1 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01319266: Completed Phase 1 study, sponsored by Cephalon.
NCT01319266 is a Phase 1 study that has completed, run by Cephalon. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01319266, a Phase 1 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of varying degrees of renal impairment (mild, moderate, severe and end stage renal disease) compared with subjects with normal renal function on the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
Interventions
- DRUG Hydrocodone Bitartrate extended-release tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
What the finished NCT01319266 record still lists
NCT01319266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Hydrocodone Bitartrate extended-release tablet is the first listed.
NCT01319266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01319266 about?
NCT01319266 is a clinical study titled "A Study to Assess the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Renal Function and Subjects With Varying Degrees of Renal Impairment". The purpose of this study is to assess the effect of varying degrees of renal impairment (mild, moderate, severe and end stage renal disease) compared with subjects with normal renal function on the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
What is the current status of trial NCT01319266?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2011-03. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01319266?
The interventions under investigation include: Hydrocodone Bitartrate extended-release tablet (DRUG).
Who is sponsoring clinical trial NCT01319266?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01319266's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 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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