drugset / Trial / NCT01319279
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
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2011-04
- Primary completion
- 2011-08
- Completion
- 2011-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydrocodone | Unknown | 15 mg | — |
Indications
No indication recorded.