NCT01319266View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2011

Conditions

Renal Impairment

Interventions

DRUG

Hydrocodone Bitartrate extended-release tablet

Hydrocodone bitartrate extended-release oral tablet will be administered at a dose of 45 mg and dosed one time on Day 1. Subjects will also be dosed with naltrexone hydrochloride to block opioid effects.

Trial Locations (4)

32809

Orlando Clinical Research, Orlando

33014

Clinical Pharmacology of Miami, Miami

37920

New Orleans Center, Knoxville

55404

DaVita, Minneapolis