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

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rotigotine transdermal patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotigotine in Healthy Japanese<br>Rotigotine transdermal patch Single dose application of 2 mg / 24 hours Rotigotine in Healthy Japanese subjects Transdermal patch over 24 hours | Drug: Rotigotine transdermal patch<br>* Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)<br>* Other names: Neupro;|
| Experimental: Rotigotine in Caucasian<br>Rotigotine transdermal patch Single-Dose application of 2 mg / 24 hours Rotigotine in healthy Caucasian subjects Transdermal patch over 24 hours | Drug: Rotigotine transdermal patch<br>* Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)<br>* Other names: Neupro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve (AUC) from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of unconjugated Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized [AUC (0-t)norm] of unconjugated Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Maximum concentration in plasma [Cmax] of unconjugated Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Maximum concentration in plasma normalized by body weight [Cmax,norm] of unconjugated Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Maximum concentration in plasma [Cmax] of total Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Despropylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized by body weight [AUC (0-t)] of total Despropylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Maximum concentration in plasma [Cmax] of total Despropylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Despropylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Desthienylethylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized by body weight [AUC (0-t)] of total Desthienylethylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Maximum concentration in plasma [Cmax] of total Desthienylethylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Maximum concentration in plasma normalized by body weight [Cmax, norm] of total Desthienylethylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal half-life [t1/2] of unconjugated Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Time of maximum concentration [tmax] of unconjugated Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of unconjugated Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Total body clearance (CL) of unconjugated Rotigotine normalized by body weight (BW) [CL/f/BW] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Apparent volume of distribution of unconjugated Rotigotine normalized by body weight [Vz/f/BW] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Amounts of unconjugated Rotigotine excreted in urine [Ae] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Fraction of unconjugated Rotigotine excreted into urine [fe (% of dose)] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Renal Clearance [CLR] of unconjugated Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Terminal half-life [t1/2] of total Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Time of maximum concentration [tmax] of total Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Total body clearance of total Rotigotine normalized by body weight [CL/f/BW] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Apparent volume of distribution normalized of total Rotigotine by body weight [Vz/f/BW] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Amount of total Rotigotine excreted into urine [Ae] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Fraction of total Rotigotine excreted into urine [fe (% of dose)] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Renal clearance [CLR] of total Rotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Terminal half-life [t1/2] of total Despropylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Time of maximum concentration [tmax] of total Despropylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Despropylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Total body clearance of total Despropylrotigotine normalized by body weight [CL/f/BW] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Apparent volume of distribution of total Despropylrotigotine normalized by body weight [Vz/f/BW] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Amount of total Despropylrotigotine excreted into urine [Ae] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Fraction of total Despropylrotigotine excreted into urine [fe (% of dose)] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Renal Clearance [CLR] of total Despropylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Terminal half-life [t1/2] of total Desthienylethylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Time of maximum concentration [tmax] of total Desthienylethylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Desthienylethylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Total body clearance of total Desthienylethylrotigotine normalized by body weight [CL/f/BW] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Apparent volume of distribution of total Desthienylethylrotigotine normalized by body weight [Vz/f/BW] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Amount of total Desthienylethylrotigotine excreted into urine [Ae] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Fraction of total Desthienylethylrotigotine excreted into urine [fe (%of dose)] | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 
| Renal clearance [CLR] of total Desthienylethylrotigotine | Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose | From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotigotine, Neupro, Japanese, Caucasian, Male, Female, Single dose, Pharmacokinetics