The Comparative Pilot Bioavailability Study of a Generic Test Formulation of Selegiline TDS 6 mg/24 Hours Against the Comparator EMSAM® 6 mg/24 Hours in Healthy Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Plasma Pharmacokinetic-AUC 0-t
研究概览
简要总结
The goal of this clinical study is to obtain the bioavailability of the test patch of a generic formulation of Selegiline TDS 6mg/24 hours by Corium Innovations against the comparator (EMSAM), and the systemic and local safety and tolerability will be also observed and evaluated.
详细描述
This is a pilot, single-dose, single-centre, open-label, randomised, 2-way crossover study (2 treatments, 2 periods and 2 sequences) of a generic test formulation of Selegiline TDS 6 mg/24 hours with the comparator EMSAM® TDS 6 mg/24 hours, with at least 14 days washout period, recruiting around 12 healthy male and female subjects.
For each study period, subjects will be admitted and confined in the clinical study site the night before the study day from at least 10 hours before dosing and they will be discharged once all PK, safety and tolerability are completed at 36 hours after dosing. Subjects will be required to return for subsequent PK, safety and tolerability at 48-, 72- and 96-hours post-dosing. The clinic will follow up by telephone 7 ± 3 days after completion of the study.
Pharmacokinetic Blood Sampling:
PK blood samples will be collected before dosing and at 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 30, 36, 48, 72, 96 hours after dosing.
Pharmacokinetics:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject age between 18 to 55 years old with adequate contraception but without taking oral contraceptives.
- •Subject body weight ≤ 120 kg, with a BMI within 18-30 kg/m².
- •Subject is able to complete the clinical study including the follow-up.
- •Subject is capable of providing written informed consent.
- •Subjects are able and willing to follow the requirements of the study and wearing patches.
排除标准
- •Breastfeeding female.
- •Pregnancy test positive female.
- •At rest systolic blood pressure outside 90-140 mmHg or diastolic blood pressure outside 50- 90 mmHg or orthostatic hypotension.
- •At rest sinus bradycardia defined as symptomatic heart rate < 50 bpm, or asymptomatic heart rate < 45 bpm; and sinus tachycardia defined as heart rate > 100 bpm.
- •Clinically significant ECG abnormalities (PQ interval > 0.2 s, Duration of the QRS complex > 0.1 s, AV block).
- •QTc > 450 ms for male and > 460 ms for female.
- •A history of allergies, or any significant adverse reactions, to any medications, unless the clinician considers that they are not clinically significant.
- •Clinically significant medical history of eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, genitourinary, neurological, haematopoietic, lymphatic, endocrine, metabolic, dermatological, musculoskeletal, psychological, family history or surgical history.
- •Family history of sudden cardiac death or pheochromocytoma.
- •Clinically significant physical examination finding or psychiatric unstable conditions or psychiatric illness requiring treatment.
- •Clinically significant laboratory abnormalities.
- •Haemoglobin < 12.0 g/dL for male and < 11.0 g/dL for female at screening.
- •Total bilirubin > 1.25 x upper limit of normal, ALT/AST > 1.5 x upper limit of normal.
- •Hepatitis B, Hepatitis C or HIV positive.
- •Urine DOA test positive.
- •Breath alcohol test positive.
- •Any smoker with tobacco or electronic tobacco products.
- •A history of drug or substance abuse, including alcohol (≥ 14 units per week) within 6 months before consent taking (1 unit of alcohol equals approximately ½ pint [285 mL] of beer, 1 glass [125 mL] of wine, or 1 shot [25 mL] of spirit).
- •Taking selective serotonin reuptake inhibitors (SSRI), serotonin and norepinephrine reuptake inhibitors (SNRI) or cough or cold medicine (e.g., dextromethorphan, pseudoephedrine) or using carbamazepine or oxcarbazepine, or using meperidine and analgesic agents such as tramadol, methadone, and propoxyphene, or using sympathomimetic agents.
- •Unable to refrain from taking any medications (including herbal remedies) within 7 days before dosing, with the exception of birth control medications and other medications deemed acceptable by the Investigator.
- •Clinically significant illness or injury or hospitalisation for any reason within 28 days before consent taking.
研究组 & 干预措施
Group1: Selegiline TDS of test formulation (6mg/24 hours)
Group1: 1 x Selegiline TDS 6 mg/24 hours manufactured by Corium Innovations, Inc., worn over 24 hours on cleaned upper left or right arm approximately from 8 AM following the randomisation schedule.
干预措施: Pharmacokinetic profiles of Selegiline TDS and EMSAM (Drug)
Group2: EMSAM TDS (6 mg/24 hours)
1 x EMSAM® TDS 6 mg/24 hours manufactured by Somerset Pharmaceuticals, Inc., worn over 24 hours on cleaned upper left or right arm approximately from 8 AM following the randomisation schedule.
干预措施: Pharmacokinetic profiles of Selegiline TDS and EMSAM (Drug)
结局指标
主要结局
Plasma Pharmacokinetic-AUC 0-t
时间窗: 22 days
The area under the plasma concentration-time curve from time 0 to the last measurable concentration is calculated by the linear/log trapezoidal method where the liner trapezoidal method is applied up to Tmax and the log trapezoidal method is used after Tmax.
Plasma Pharmacokinetic-AUC 0-∞
时间窗: 22 days
The area under the plasma concentration-time curve from time 0 to infinity is calculated as the sum of AUC0-t and Ct/Kel, where Ct is the last measurable concentration.
Plasma Pharmacokinetic-Cmax
时间窗: 22 days
The maximum plasma concentration following drug administration
Plasma Pharmacokinetic-Tmax
时间窗: 22 days
The time to achieve maximum plasma concentration is determined directly from the individual plasma concentration-time curves
Plasma Pharmacokinetic-T1/2
时间窗: 22 days
The terminal elimination half-life is calculated as 0.693/Kel
Plasma Pharmacokinetic-Tlag
时间窗: 22 days
The time prior to achieving the first measurable plasma concentration (if applicable)
Plasma Pharmacokinetic-MTR
时间窗: 22 days
The mean residence time
Plasma Pharmacokinetic-λz (Lambda z)
时间窗: 22 days
Individual estimate of the terminal elimination rate constant, calculated using log-linear regression of the terminal portions of the plasma concentration-versus-time curves
次要结局
- Safety-Topic Skin Irritation(22 days)