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

Healthy Clinical Trial

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

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00388219
Study type Interventional
Source Grünenthal GmbH
Contact
Status Terminated
Phase Phase 1
Start date October 2006
Completion date November 2006
View Details
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