NCT03785613

Clinical Pilot Study in Healthy Men to Characterize the Uptake of Buprenorphine Into and Its Elimination From the Body After Topical Application of Two New Forms of a Skin Patch in Comparison to a Reference Patch

Pilot Study to Investigate the Pharmacokinetic Characteristics of Two Buprenorphine Transdermal Patch Formulations as Compared to a Reference Patch

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is intended to produce information on the pharmacokinetic characteristics (uptake into and elimination from the body) of two new patch formulations of the analgesic buprenorphine as compared to the reference patch Transtec (Registered Trademark) 35 micrograms per hour (μg/h) in order to assess the suitability of the test formulations for a later confirmatory bioequivalence study. In addition to a reduced buprenorphine load, the new patch formulations may potentially provide improved wearing properties. A placebo patch formulation of the respective test or reference patch will be applied simultaneously to explore the skin tolerability and skin adhesiveness of the patch formulations. Furthermore, the safety and tolerability of the treatments will be assessed.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Test Product T1: Buprenorphine patch (9 mg)	Buprenorphine transdermal patch formulation, containing 9 milligrams buprenorphine in an active surface area of 25 square centimeters.
DRUG	Test Product T2: Buprenorphine patch (3.8 mg)	Buprenorphine transdermal patch formulation, containing 3.8 milligrams buprenorphine in an active surface area of 10 square centimeters.
DRUG	Reference Product R: Transtec patch (20 mg)	Transtec (Registered Trademark) transdermal patch containing 20 milligrams buprenorphine in an active surface area of 25 square centimeters, release rate 35 micrograms per hour.
DRUG	Matching placebo patch to T1	Placebo patch to T1.
DRUG	Matching placebo patch to T2	Placebo patch to T2.
DRUG	Matching placebo patch to R	Placebo patch to R.

Timeline

• Start date: 2005-11-07
• Primary completion: 2006-03-14
• Completion: 2006-03-14
• First posted: 2018-12-24
• Last updated: 2018-12-24

Locations

1 site across 1 country: Switzerland