Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects

PHASE4CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

May 31, 2013

Conditions
Hepatic FailureHepatic ImpairmentChronic Hepatitis C Infection With Hepatic Coma
Interventions
DRUG

2.0mg Buprenorphine/0.5mg Naloxone

Each participant received a single sublingual dose of Suboxone® on Day 1 following a fast of at least 8 hours prior to dosing and 2 hours after dosing.

DRUG

Promethazine

Each participant received a 25-mg or 50-mg promethazine oral dose 30 minutes before Suboxone® administration and then 25-mg promethazine orally or by rectal suppositories every 4 hours as needed for nausea and vomiting during the first 48 hours after Suboxone® administration.

Trial Locations (3)

32809

Orlando Clinical Research Center, Orlando

78215

American Research Corporation (ARC), San Antonio

33014-3616

Clinical Pharmacology of Miami, Inc., Hialeah

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Indivior Inc.

INDUSTRY

NCT01846455 - Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects | Biotech Hunter | Biotech Hunter