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Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects

NCT01846455 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2016-10-24

Study results available
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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.

Conditions

  • Hepatic Failure
  • Hepatic Impairment
  • Chronic 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.

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Lasseter, MD · Clinical Pharmacology of Miami, Inc.

  • Thomas Marabury, MD · Orlando Clinical Research Center

  • Eric J. Lawitz, MD · American Research Corporation (ARC)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-04-30
Completion
2013-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01846455 on ClinicalTrials.gov