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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Rotigotine transdermal patch

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany
    • 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotigotine in Healthy Japanese; 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; Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2); Other Names: Neupro
Experimental: Rotigotine in Caucasian; 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; Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2); Other Names: Neupro

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (Actual): October 1, 2002
• Study Completion (Actual): December 1, 2002

Study Registration Dates

• First Submitted: January 3, 2013
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Estimate): October 20, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Japanese; Female; Male; Rotigotine; Neupro; Single dose; Caucasian
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Rotigotine
• Other Study ID Numbers: SP0717