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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UCB Pharma
• Treatments: N 0437; Rotigotine

Criteria

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