Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body

• Status: Completed
• Trial end date: 2009-08-01
• 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 sites.

• 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