Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations
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 multiple dose application.
Drug: Patch with centrally acting analgesic
Drug: Transtec(R) PRO (buprenorphine)
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multiple Dose Bioequivalence Trial Comparing a New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch.|
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||December 2006|
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 after multiple patch application. Pharmacokinetic target parameters are AUCss,Tau and Css,max.
Further: To assess the safety, tolerability, skin tolerability and adhesiveness of the patch applications. To evalute the following further Pharmacokinetic parameters: Css,min, Css,ave, PTF, Swing, tss,max, and t1/2,z