Study to Evaluate the Pharmacokinetics (PK), Safety, Tolerability of Single-Dose Transdermal Rotigotine in Japanese and Caucasian Healthy Male / Female Subjects

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian Female and Male Healthy Subjects.

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

Details

• Lead Sponsor: UCB BIOSCIENCES GmbH
• Collaborators: 40789 Monheim am Rhein; Alfred-Nobel-Str. 10; Schwarz BioSciences GmbH
• Treatments: N 0437; Rotigotine

Criteria

Inclusion Criteria:

• Subject is healthy according to assessments done at eligibility assessment (medical history, physical examination, blood pressure, heart rate, Electrocardiogram (ECG), hematology, clinical chemistry, urinalysis)

• Subject is of normal body-weight as determined by a body mass index ranging between 18 to 28 kg / m²

• Subject is Japanese or Caucasian. Japanese subjects are born in Japan and left Japan not more than 10 years ago. Both parents of the Japanese subjects are 100 % Japanese

Exclusion Criteria:

• Subjects (females) without medically adequate contraception (e.g. mechanical contraception (Intrauterine-Device IUD), sterilization, hysterectomy) or on lactation or pregnant women. Subjects with oral contraception or hormone replacement within 4 weeks prior to eligibility assessment

• Subject has a history of chronic alcohol or drug abuse

• Subject has a consumption of more than 20 g of alcohol / day (amount corresponds to 0.5 l of beer / day or 0.25 l of wine / day or 3 glasses (à 2 cl) of liquor / day

• Subject has a clinically relevant allergy

• Subject has a known or suspected drug hypersensitivity in particular, to any component of the trial medication

• Subject has any clinically significant abnormality in physical examination

• Subject has a heart rate at rest less than 50 beats per minute (bpm) or more than 100 bpm

• Subject has systolic blood pressure lower than 100 mmHg or higher than 145 mmHg or diastolic blood pressure higher than 95 mmHg or lower than 60 mmHg

• Subject has an atopic or eczematous dermatitis and / or an active skin disease or skin tumors

• Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis