Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID 297307)
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469404
|Principal Investigator:||Wolfgang Timmer, Dr.||CRS Clinical Research Services Mannheim|