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

Single-site, Open-label, Randomized, Cross-over Trial to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (4.5mg/10cm^2) From 2 Different Manufacturing Processes

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.

Inclusion Criteria:

• Healthy White, male volunteers between 18 and 55 years of age (inclusive).
• BMI between 19 and 28 kg/m² (inclusive).

Exclusion Criteria:

• Previous participation in a clinical study with rotigotine
• History or current condition of epilepsy and/or seizures.
• Known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity.
• History of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis.
• History or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease.
• Clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations.
• Positive HIV, hepatitis B or C test or positive alcohol or drug test.
• Relevant hepatic or renal dysfunction
• Intake of medication that might interfere with the test drug within 2 weeks prior to dosing.
• Thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites