NCT02839122已完成1 期
A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects
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
- 28
- 主要终点
- Area Under the Curve(AUC) of Tadalafil, Dutasteride
研究概览
简要总结
This is open-Label, A Randomized, Crossover study to evaluate the safety and pharmacokinetic interaction after oral concomitant administration of Dutasteride and Tadalafil 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
- Prevention
- 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
- •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
- •Excessive alcohol consumption (> 3 units/week, 1 unit)
- •Taking food which may affect Clinical trial within 7 days
- •Positive result from Urinary test, Serum test
- •Not eligible due to other reasons including laboratory results
- •Clinically significant disorders result from Electrocardiography test
- •Not eligible due to investigator's judgments
研究组 & 干预措施
Dutasteride, Tadalafil
Experimental
干预措施: Tadalafil (Drug)
Dutasteride, Tadalafil
Experimental
干预措施: Dutasteride (Drug)
Tadalafil, Dutasteride
Experimental
干预措施: Tadalafil (Drug)
Tadalafil, Dutasteride
Experimental
干预措施: Dutasteride (Drug)
结局指标
主要结局
Area Under the Curve(AUC) of Tadalafil, Dutasteride
时间窗: 0,24,72,96,96.5,97,97.5,98,99,100,102,104,106,108,120,120.5,121,121.5,122,122.5,123,123.5,124,125,126,128,132,144,152,168,192,216,264,312,360 hours
Area Under the Curve(AUC) of Dutasteride
时间窗: 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,32,48,72,96,144,192,240 hours
次要结局
未报告次要终点
研究者
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