NCT00469404

Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID 297307)

Single Dose Bioequivalence Trial Comparing a Down-Scaled New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch.

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

Summary

The purpose of this study is to determine whether the plasma levels of two different analgesic transdermal patch formulations lead to same plasma levels of the active ingredient after single dose application.

Detailed description

Main: To demonstrate the bioequivalence between the two transdermal analgesic formulations after single patch application. Pharmacokinetic target parameters are AUC, AUC0-t, and Cmax. Further: To assess the safety, tolerability, skin tolerability and adhesiveness of the patch applications.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Buprenorphine

Timeline

• Start date: 2007-05-01
• Completion: 2007-11-01
• First posted: 2007-05-04
• Last updated: 2007-11-16

Locations

1 site across 1 country: Germany