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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03770234
Study type Interventional
Source Grünenthal GmbH
Contact
Status Completed
Phase Phase 1
Start date April 5, 2004
Completion date May 26, 2004

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