NCT00387777

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

Multiple Dose Bioequivalence Trial Comparing a New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Grünenthal GmbH · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 multiple dose application.

Detailed 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 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 evaluate the following further Pharmacokinetic parameters: Css,min, Css,ave, PTF, Swing, tss,max, and t1/2,z

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Patch with centrally acting analgesic
DRUG	Transtec(R) PRO (buprenorphine)

Timeline

• Start date: 2006-10-01
• Completion: 2006-12-01
• First posted: 2006-10-13
• Last updated: 2016-01-11

Locations

1 site across 1 country: Germany