Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects

Phase 4 Completed 43 enrolled Indivior Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.

Timeline

Start: 2012-09
Primary completion: 2013-04
Completion: 2013-05

Publications

Results Nasser AF, Heidbreder C, Liu Y, Fudala PJ. Pharmacokinetics of Sublingual Buprenorphine and Naloxone in Subjects with Mild to Severe Hepatic Impairment (Child-Pugh Classes A, B, and C), in Hepatitis C Virus-Seropositive Subjects, and in Healthy Volunteers. Clin Pharmacokinet. 2015 Aug;54(8):837-49. doi: 10.1007/s40262-015-0238-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buprenorphine	Other / unclassified	2 mg	Other
Subject	Naloxone	Small molecule	0.5 mg	Other
Background	Promethazine	Small molecule	25 mg	Oral
Background	Promethazine	Small molecule	50 mg	Oral

Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects

Summary

Timeline

Publications

Drugs

Indications