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

UCB Pharma0 个研究点目标入组 48 人开始时间: 2006年12月最近更新: 2014年10月20日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: UCB Pharma
入组人数: 48
主要终点: Plasma concentrations of total Rotigotine

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 19 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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)

排除标准

•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)
•Subject has a positive test for Human Immunodeficiency Virus antibodies (HIV)-1/2Ab, Hepatitis B surface Antigen (HBsAg) or Hepatitis C Virus Antibody (HCV-Ab)
•Subject has a positive test for alcohol or drugs
•Subject consumes more than 150 g of alcohol / week
•Subject has made a blood donation or had a comparable blood loss (> 400 ml) within the last 3 months
•Subject smokes more than 5 cigarettes per day or has done so within previous 6 months
•Subject has a clinically relevant allergy
•Subject is taking any medication (excluding oral hormonal contraceptive) currently or within 2 weeks prior to the first day of dosing (with the exception of Acetaminophen [up to 1000 mg per day per os] which may have been taken up to 48 hours prior to commencement of dosing)
•Female subject is currently taking an oral hormonal contraceptive but less than 2 months
•Subject has a symptomatic orthostatic hypotension with a decrease of Blood Pressure (BP) from supine to standing position of ≥ 20 mmHg in systolic BP or of ≥ 10 mmHg in diastolic BP after 1 and / or 3 minutes
•Subject has a pulse rate at rest less than 45 beats per minute or more than 100 beats per minute (measured in supine position)
•Subject has a systolic Blood Pressure (BP) lower than 100 mmHg or higher than 150 mmHg or diastolic BP higher than 95 mmHg (measured in supine position)
•Subject has a current or a history of clinically relevant motor disturbance, impairment of memory, sleep disturbance or neurodegenerative disease (e.g. , Alzheimer Dementia, Diffuse, Lewy Body Dementia, Amyotrophic Lateral Sclerosis [ALS], Multiple Sclerosis)
•Subject has taken herbal medicine therapy within the last 2 weeks
•Subject consumes more than 3 cups (more than 450 ml) of caffeinated beverages per day within the last 2 weeks

研究组 & 干预措施

Rotigotine group

Experimental

干预措施: Rotigotine (Drug)

Placebo group

Placebo Comparator

Placebo matched to rotigotine will be administered in the same way as within the Rotigotine group.

干预措施: Placebo (Other)