NCT03770234

Clinical Study in Healthy Men to Investigate the Uptake of Buprenorphine and Its Elimination From the Body After Dermal Application as Patches for 96 Hours and for 72 Hours

Investigation of the Pharmacokinetics of a Transtec® 35 µg/h Transdermal Patch Application for 96 Hours and a Patch Application for 72 Hours in an Open, Randomised, Single Application, Two-period Crossover, Phase I Study in 30 Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: Male
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study was to investigate the pharmacokinetics (i.e. the uptake, distribution and elimination from the body) of dermally applied buprenorphine during and after different application periods, i.e., a 96-hour and a 72-hour application of the Transtec (Registered Trademark) patch (release rate 35 micrograms per hour \[µg/hour\]). In the Transtec summary of product characteristics (prescribing information for the physician), the wearing time per patch is restricted to three days (72 hours) after which the patch has to be replaced. However, market experience has shown that the Transtec patches are sometimes worn for a period longer than three days, i.e. they sometimes happen to be only replaced every four days. There was currently no data available as how to evaluate this longer wearing period.

Conditions

• Pain
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Transtec 35 µg/hour transdermal patch	Transdermal patch containing 20 mg buprenorphine in an active surface area of 25 squared centimeters. Buprenorphine release rate 35 µg/hour.

Timeline

• Start date: 2004-04-05
• Primary completion: 2004-05-26
• Completion: 2004-05-26
• First posted: 2018-12-10
• Last updated: 2018-12-10

Locations

1 site across 1 country: Germany