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NCT01319279 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment
A Phase 1 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01319279 is a Phase 1 study that has completed, run by Cephalon. The registered enrollment target is 16 participants.
The verdict
NCT01319279, a Phase 1 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is: 1. To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function. 2. To assess the safety and tolerability of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function.
Interventions
- DRUG Hydrocodone bitartrate extended-release tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-04 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01319279
The ClinicalTrials.gov registry entry for NCT01319279 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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.
NCT01319279 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01319279 about?
NCT01319279 is a clinical study titled "A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment". The purpose of this study is: 1. To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function. 2. To assess the safety and tolerability of the hydrocodone bitartrate extended-release ta...
What is the current status of trial NCT01319279?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2011-04. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01319279?
The interventions under investigation include: Hydrocodone bitartrate extended-release tablet (DRUG).
Who is sponsoring clinical trial NCT01319279?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
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