Trial | NCT01761526  Report issue

Title

Study to Evaluate the Pharmacokinetics (PK), Safety, Tolerability of Single-Dose Transdermal Rotigotine in Japanese and Caucasian Healthy Male / Female Subjects
Parallel Group Trial to Evaluate the Pharmacokinetics and Safety / Tolerability of Single-Dose Treatment With Rotigotine Continuous Delivery System (10 cm2 / 4.5 mg) in Japanese and Caucasian Healthy Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rotigotine ...

  • Study Participants

    50
To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian Female and Male Healthy Subjects.
Study Started
Oct 31
2002
Primary Completion
Oct 31
2002
Study Completion
Dec 31
2002
Last Update
Oct 20
2014
Estimate

Drug Rotigotine transdermal patch

Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)

  • Other names: Neupro

Rotigotine in Healthy Japanese Experimental

Rotigotine transdermal patch Single dose application of 2 mg / 24 hours Rotigotine in Healthy Japanese subjects Transdermal patch over 24 hours

Rotigotine in Caucasian Experimental

Rotigotine transdermal patch Single-Dose application of 2 mg / 24 hours Rotigotine in healthy Caucasian subjects Transdermal patch over 24 hours

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
No Results Posted