drugset / Trial / NCT01319266

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

NCT01319266

Phase 1 Completed 55 enrolled Cephalon
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-03
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocodone Unknown 45 mg Oral