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Completed

NCT Number: NCT01761526

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

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

01

Neuss, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotigotine transdermal patch

Drug

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

Other names: Neupro

Primary outcomes

  1. 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

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  2. 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

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  3. Maximum concentration in plasma [Cmax] of unconjugated Rotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  4. Maximum concentration in plasma normalized by body weight [Cmax,norm] of unconjugated Rotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  5. 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

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  6. Maximum concentration in plasma [Cmax] of total Rotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  7. Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Rotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  8. 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

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  9. 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

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  10. Maximum concentration in plasma [Cmax] of total Despropylrotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  11. Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Despropylrotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  12. 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

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  13. 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

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  14. Maximum concentration in plasma [Cmax] of total Desthienylethylrotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  15. Maximum concentration in plasma normalized by body weight [Cmax, norm] of total Desthienylethylrotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

Secondary outcomes

  1. Terminal half-life [t1/2] of unconjugated Rotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  2. Time of maximum concentration [tmax] of unconjugated Rotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  3. Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of unconjugated Rotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  4. Total body clearance (CL) of unconjugated Rotigotine normalized by body weight (BW) [CL/f/BW]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  5. Apparent volume of distribution of unconjugated Rotigotine normalized by body weight [Vz/f/BW]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  6. Amounts of unconjugated Rotigotine excreted in urine [Ae]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  7. Fraction of unconjugated Rotigotine excreted into urine [fe (% of dose)]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  8. Renal Clearance [CLR] of unconjugated Rotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  9. Terminal half-life [t1/2] of total Rotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  10. Time of maximum concentration [tmax] of total Rotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  11. Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Rotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  12. Total body clearance of total Rotigotine normalized by body weight [CL/f/BW]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  13. Apparent volume of distribution normalized of total Rotigotine by body weight [Vz/f/BW]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  14. Amount of total Rotigotine excreted into urine [Ae]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  15. Fraction of total Rotigotine excreted into urine [fe (% of dose)]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  16. Renal clearance [CLR] of total Rotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  17. Terminal half-life [t1/2] of total Despropylrotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  18. Time of maximum concentration [tmax] of total Despropylrotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  19. Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Despropylrotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  20. Total body clearance of total Despropylrotigotine normalized by body weight [CL/f/BW]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  21. Apparent volume of distribution of total Despropylrotigotine normalized by body weight [Vz/f/BW]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  22. Amount of total Despropylrotigotine excreted into urine [Ae]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  23. Fraction of total Despropylrotigotine excreted into urine [fe (% of dose)]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  24. Renal Clearance [CLR] of total Despropylrotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  25. Terminal half-life [t1/2] of total Desthienylethylrotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  26. Time of maximum concentration [tmax] of total Desthienylethylrotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  27. Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Desthienylethylrotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  28. Total body clearance of total Desthienylethylrotigotine normalized by body weight [CL/f/BW]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  29. Apparent volume of distribution of total Desthienylethylrotigotine normalized by body weight [Vz/f/BW]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  30. Amount of total Desthienylethylrotigotine excreted into urine [Ae]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  31. Fraction of total Desthienylethylrotigotine excreted into urine [fe (%of dose)]

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

  32. Renal clearance [CLR] of total Desthienylethylrotigotine

    Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-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

Sponsors and collaborators

Lead sponsor

UCB BIOSCIENCES GmbH

Industry

Collaborators

  • 40789 Monheim am Rhein
  • Alfred-Nobel-Str. 10
  • Schwarz BioSciences GmbH

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Jan 4, 2013
Registry last updated
Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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