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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 is a Phase 1 study that has completed, run by Cephalon. The registered enrollment target is 55 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01319266
The ClinicalTrials.gov registry entry for NCT01319266 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cephalon, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hydrocodone Bitartrate extended-release tablet is the first listed.
NCT01319266 reports 0 study locations.
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.
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