CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 43 enrolled
Drug / intervention
2.0mg Buprenorphine/0.5mg Naloxone +1 moredrug
Likely dose
2.0mg Buprenorphine/0.5mg Naloxonefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01846455
NCT01846455Phase 4Completed
CompareCT.gov

Pharmacokinetics of Buprenorphine and Naloxone in Subjects With Mild to Severe Hepatic Impairment (Child-Pugh Classes, A, B, and C), in HCV-Seropositive Subjects, and in Healthy Volunteers

Indivior Inc.·interventional·Posted May 3, 2013·Updated Oct 24, 2016

In Brief

A Phase 4 clinical trial evaluating 2.0mg Buprenorphine/0.5mg Naloxone and Promethazine for Hepatic Failure and 2 related conditions. Completed, enrolled 43 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Failure, Hepatic Impairment, Chronic Hepatitis C Infection With Hepatic Coma
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 3, 2013
Enrollment StartSep 1, 2012
Primary CompletionApr 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.2 years ago

Interventions

2.0mg Buprenorphine/0.5mg Naloxonedrug

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.

Promethazinedrug

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.