NCT01259102

Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods

A Parallel Open-Label Study to Examine Plasma Concentrations of Buprenorphine Following Reapplication of 10-mg Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals.

Detailed description

The purpose of this study is to determine the minimum application site rest period that ensures that reapplication of BTDS 10 to the same site in the deltoid region does not result in increased absorption of drug in normal healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal patch	Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.

Timeline

• Start date: 2000-11-01
• Primary completion: 2001-03-01
• Completion: 2001-03-01
• First posted: 2010-12-13
• Last updated: 2012-09-03
• Results posted: 2011-02-07

Locations

1 site across 1 country: United States