NCT01259115

Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole

A Single Center, Randomized, Double-Blind, Crossover Study to Assess Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of BTDS and Ketoconazole, Used As a CYP3A4 Inhibitor, in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the pharmacokinetics of buprenorphine and its metabolites in the presence and absence of ketoconazole.

Detailed description

To assess the pharmacokinetics of buprenorphine and its metabolites (nor-buprenorphine, buprenorphine 3 glucuronide and nor-buprenorphine glucuronide) in the presence and absence of ketoconazole. Safety evaluation of BTDS and ketoconazole in healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal patch	Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.
DRUG	Ketoconazole tablet	Ketoconazole 200 mg tablets taken orally twice daily.
DRUG	Placebo to match ketoconazole tablet	Placebo to match ketoconazole 200 mg tablets taken orally twice daily.

Timeline

• Start date: 2002-10-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2010-12-13
• Last updated: 2014-05-19
• Results posted: 2011-01-26

Locations

1 site across 1 country: United States