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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian Female and Male Healthy Subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Rotigotine transdermal patch (Drug)
Rotigotine in Caucasian
- Rotigotine transdermal patch
- Single-Dose application of 2 mg / 24 hours Rotigotine in healthy Caucasian subjects
- Transdermal patch over 24 hours
干预措施: Rotigotine transdermal patch (Drug)
结局指标
主要结局
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
时间窗: 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
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
时间窗: 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
Maximum concentration in plasma [Cmax] of unconjugated Rotigotine
时间窗: 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
Maximum concentration in plasma normalized by body weight [Cmax,norm] of unconjugated Rotigotine
时间窗: 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
Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Rotigotine
时间窗: 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
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
时间窗: 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
Maximum concentration in plasma [Cmax] of total Rotigotine
时间窗: 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
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
时间窗: 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
Maximum concentration in plasma normalized by body weight [Cmax, norm] of total Desthienylethylrotigotine
时间窗: 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
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
时间窗: 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
Maximum concentration in plasma [Cmax] of total Despropylrotigotine
时间窗: 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
Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Despropylrotigotine
时间窗: 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
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
时间窗: 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
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
时间窗: 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
Maximum concentration in plasma [Cmax] of total Desthienylethylrotigotine
时间窗: 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
次要结局
- Terminal half-life [t1/2] of unconjugated Rotigotine(From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Time of maximum concentration [tmax] of unconjugated Rotigotine(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(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](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](From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Renal Clearance [CLR] of unconjugated Rotigotine(From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Amounts of unconjugated Rotigotine excreted in urine [Ae](From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Fraction of unconjugated Rotigotine excreted into urine [fe (% of dose)](From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Terminal half-life [t1/2] of total Rotigotine(From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Time of maximum concentration [tmax] of total Rotigotine(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(From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Amount of total Rotigotine excreted into urine [Ae](From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Renal clearance [CLR] of total Rotigotine(From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Time of maximum concentration [tmax] of total Despropylrotigotine(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(From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Time of maximum concentration [tmax] of total Desthienylethylrotigotine(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(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](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](From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Fraction of total Despropylrotigotine excreted into urine [fe (% of 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](From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Amount of total Desthienylethylrotigotine excreted into urine [Ae](From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Fraction of total Desthienylethylrotigotine excreted into urine [fe (%of dose)](From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Renal clearance [CLR] of total Desthienylethylrotigotine(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](From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Terminal half-life [t1/2] of total Despropylrotigotine(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](From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Fraction of total Rotigotine excreted into urine [fe (% of 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](From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Amount of total Despropylrotigotine excreted into urine [Ae](From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Renal Clearance [CLR] of total Despropylrotigotine(From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)
- Terminal half-life [t1/2] of total Desthienylethylrotigotine(From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose)