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

Outcome

Met primary endpoint

paper In both studies, 90% CIs for ratios of AUC(0-tz) and Cmax were within the bioequivalence acceptance range (0.8-1.25). PMID 24006953 ↗

registry ratio of geometric LS- Means 0.9864 (90% CI 0.9103 to 1.0688) NCT00881894 ↗

registry ratio of geometric LS- Means 0.9584 (90% CI 0.8861 to 1.0367) NCT00881894 ↗

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.