NCT00388219

Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations

Single Dose Bioequivalence Trial Comparing a New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Grünenthal GmbH · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether Transtec (R) PRO 70 µg/h and a new buprenorphine patch formulation lead to same plasma levels of buprenorphine after single dose application

Detailed description

Main: to demonstrate the bioequivalence of the new buprenorphine transdermal patch T2rev formulation containing 13 mg buprenorphine (Test) as compared to Transtec (R) PRO 70 µg/h patch transdermal patch containing 40 mg buprenorphine as reference (Reference) after single patch application. Pharmacokinetic target parameters are AUC, AUCo-t, and Cmax. Further: To assess the safety, tolerability, skin tolerability and adhesiveness of the patch applications

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Transtec (R) PRO (buprenorphine)

Timeline

• Start date: 2006-10-01
• Completion: 2006-11-01
• First posted: 2006-10-16
• Last updated: 2007-07-06

Locations

2 sites across 1 country: Germany