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COMPLETEDPHASE1

Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in Healthy Korean Subjects

A Single-site, Randomized, Double-blind, Placebo-controlled, Repeated-dose Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in 2 Different Dosages (2 mg / 24 Hours [10 cm2], 4 mg / 24 Hours [20 cm2]) in Healthy Korean Subjects

NCT01964573•UCB Pharma

View on ClinicalTrials.gov

Summary

The objective of this trial is to investigate the PK (Pharmacokinetic) of repeated-dose applications of the Rotigotine transdermal patch in healthy young male and female Korean subjects to be submitted to MFDS for new drug application approval.

Eligibility

Age

19 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subject is male or female and aged between 19 and 45 years of age (inclusive)
•Subject is healthy (no clinically relevant findings in any of the investigations of the pre-examination) as judged by the investigator
•Subject is of normal body weight as determined by a Body Mass Index (BMI) between 18 and 28 kg / m²
•Subject is Korean (both parents are pure Korean)

Exclusion Criteria

•Subject has had a history of drug or alcohol abuse within the last 2 years
•Subject has had a history of transient ischemic attack or stroke within the last 12 months
•Subject has a history or current condition of Epilepsy and / or seizures
•Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved Contact Dermatitis
•Subject has a history or present condition of an Atopic or Eczematous Dermatitis, Psoriasis, and / or an active skin disease
•Female subject is pregnant or lactating
•Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this trial
•Subject has a QTcB (according to Bazett´s formula) interval of ≥ 450 ms for female or ≥ 430 ms for male or any other clinically relevant Electrocardiogram (ECG) finding
•Subject has any clinically relevant abnormality in the physical examination, or any clinically relevant deviation from the normal range in the clinical chemistry, hematology, or urinalysis
•Subject has a relevant hepatic dysfunction (total Bilirubin \> 2 mg /dL or Alanine Aminotransferase \[ALT\] or Aspartate Aminotransferase \[AST\] greater than 2 times the upper limit of the normal reference range)
+14 more criteria

Locations (1)

Seoul, South Korea

Key Dates

Start Date

December 1, 2006

Primary Completion Date

February 1, 2007

Completion Date

February 1, 2007

Last Updated

October 20, 2014

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

Rotigotine

DRUG

Placebo

OTHER

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RECRUITINGPHASE1

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Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in Healthy Korean Subjects

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations