Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID 297307)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Single Dose Bioequivalence Trial Comparing a Down-Scaled New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch.|
|Study Start Date:||May 2007|
|Study Completion Date:||November 2007|
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.