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

2014-08-27 03:38:43 | BioPortfolio

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.

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.

Study Design

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

Conditions

Healthy

Intervention

Buprenorphine

Location

Site Mannheim
Mannheim
Germany

Status

Terminated

Source

Grünenthal GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:43-0400

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