Study to Compare Four Transdermal Patches

• Research type

  Research Study

• Full title

  Randomised, 4-Way, Crossover Bioavailability Study of Four Different Rotigotine 9 mg Transdermal Patch Formulations Comparing Pharmacokinetic Properties in Healthy Male Volunteers

• IRAS ID

  73895

• Contact name

  Johnston Stewart

• Sponsor organisation

  Celerion on behalf of HEXAL AG

• Eudract number

  2011-000202-22

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to compare three different formulations of a new transdermal patch designed to treat Restless Legs Syndrome and Parkinson's disease with a currently marketed patch. This study will find out how much of and the rate at which the active ingredient from each of the new formulations gets into and is removed from the body. This study will also assess the safety of and ability of the body to tolerate each of the four patches; assess how well each patch sticks to the skin; and assess any skin irritation caused by wearing each of the patches. To investigate this, volunteers will receive a single application of each of the 4 products on 4 separate occasions (i.e. 4 assessment periods, total of 4 doses) in a random order during the study. An antiemetic will be given before and after patch application in each assessment period to counter side effects. Male volunteers (aged between 20-55 years) will take part in this study at one centre in the UK. The maximum duration of the study from screening until the last visit in the final period could be up to 52 days for each volunteer (allowing for a minimum of 6 days between patch removal in one period and patch application in the following period).

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0009

• Date of REC Opinion

  28 Feb 2011

• REC opinion

  Further Information Favourable Opinion