43
Participants
Start Date
September 30, 2012
Primary Completion Date
April 30, 2013
Study Completion Date
May 31, 2013
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.
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.
Orlando Clinical Research Center, Orlando
American Research Corporation (ARC), San Antonio
Clinical Pharmacology of Miami, Inc., Hialeah
Lead Sponsor
Indivior Inc.
INDUSTRY