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

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.

Timeline

Start

2004-04-05

Primary completion

2004-05-26

Completion

2004-05-26

Drugs

Indications

No indication recorded.