Pain Clinical Trial
Official title:
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
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.
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