NCT03240939已完成1 期
A Randomized, Open Label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil Administered in Healthy Male Volunteer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
A randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil administered in healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 19 to 45 years
- •BMI score 19 kg/m2 to 28 kg/m2
- •SBP < 140 mmHg and ≤ 90 mmHg or DBP < 90 mmHg and ≥ 50 mmHg
- •Eligible according to the laboratory results of hematology, blood chemistry and urinalysis
- •Voluntarily signed the informed consent form
排除标准
- •Gastrointestinal diseases or surgery which may affect absorption of the investigational products within 6 months
- •History of hypersensitivity
- •history of Cardiovascular disease
- •History of degenerative Retina disease
- •Lactose intolerance
- •Medical history of vision loss
- •Clinically significant disorders of allergy, drug hypersensitivity reaction, hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system
- •Donated whole blood (transfusion, apheresis etc..) within 60 days
- •Participated and administered the investigational products in other clinical trial within 90 days
- •Taking drugs which may affect Clinical trial within 30 days
- •Smoked more than 10 cigarettes a day for past 30 days
- •Excessive alcohol consumption (> 3 units/week, 1 unit)
- •Taking food which may affect Clinical trial within 7 days
- •Positive result from Urinary test
- •Positive result from Serum test
- •Clinically significant disorders result from Electrocardiography test
- •Not eligible due to investigator's judgments
研究组 & 干预措施
Dutasteride&Tadalafil
Active Comparator
Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose
干预措施: Dutasteride 0.5 mg (Drug)
Dutasteride&Tadalafil
Active Comparator
Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose
干预措施: Tadalafil 5 mg (Drug)
YY-201
Experimental
YY-201 capsule, singe dose
干预措施: YY-201 (Drug)
结局指标
主要结局
Cmax
时间窗: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
"Peak Plasma Concentration" of Dutasteride, tadalafil
次要结局
- AUCinf(Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11))
- Tmax(Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11))
- t1/2β(Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11))
研究者
研究点 (1)
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