Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.

Phase 1 Completed 52 enrolled UCB Pharma

RandomizedCrossoverOpen-labelBasic science

Summary

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing processes.

Timeline

Start: 2008-10
Primary completion: 2008-11
Completion: 2008-12

Publications

Elshoff JP, Timmermann L, Schmid M, Arth C, Komenda M, Brunnert M, Bauer L. Comparison of the bioavailability and adhesiveness of different rotigotine transdermal patch formulations. Curr Med Res Opin. 2013 Dec;29(12):1657-62. doi: 10.1185/03007995.2013.841666. Epub 2013 Sep 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rotigotine	Unknown	4.5 mg	Other

Indications

No indication recorded.