A Randomized, Open-label, Single-dose, 2-treatment, 2-way, 2-period Crossover Study to Evaluate the Safety and the Pharmacokinetic Characteristics of DKF-313 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- AUClast and Cmax of dutasteride and tadalafil
研究概览
简要总结
This is a randomized, open-label, single-dose, 2-treatment, 2-way, 2-period crossover study to evaluate the safety and the pharmacokinetic characteristics of DKF-313 (dutasteride and tadalafil) in healthy male volunteers.
详细描述
This study is conducted to evaluate the pharmacokinetics of DKF-313 (dutasteride and tadalafil) comparing with the concomitant administration of AVODART and CIALIS 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 29 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 19 to 29 years
- •BMI 17.5 to 30.5 kg/m2 and body weight 55 kg or more
- •No congenital or chronic diseases within 3 years, no disease symptoms or findings
- •Eligible according to the laboratory results of hematology, blood chemistry and urinalysis and ECG
- •Voluntarily signed the informed consent form
- •Willing to participate in the study
排除标准
- •Clinically significant disorders of blood, kidney, endocrine, respiratory system, gastrointestinal system, urology, cardiovascular system, liver, psychiatry, neurology or allergy
- •Gastrointestinal diseases or surgery which may affect absorption of the investigational products
- •ALT or AST > 2xULN
- •Excessive alcohol consumption (> 210 g/week) within 6 months
- •Participated and administered the investigational products in other clinical trial within 2 months
- •SBP ≤ 100 mmHg or ≥ 150 mmHg or DBP ≤ 60 mmHg or ≥ 100 mmHg
- •History or positive result of serious alcohol or drug abuse within 1 year
- •Drugs which induce or inhibit drug metabolism within 1 month
- •Smoked more than 10 cigarettes a day
- •Prescribed drugs or over-the counter drugs within 10 days
- •Donated whole blood within 2 months or apheresis within 1 month
- •Severe acute/chronic medical and mental conditions or lab abnormalities which may increase the risk or interfere in the interpretation of study results
- •Hypersensitivity to tadalafil or phosphodiesterase type 5 inhibitor, and dutasteride or 5-α reductase inhibitor, or other drugs including aspirin, antibiotics, etc.
- •Galactose intolerance, fructose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •CYP3A4 inhibitors or CYP3A4 inducers within 2 weeks
- •Myocardial infarction within 90 days
- •Unstable angina or angina during sexual intercourse
- •Heart failure (New York Heart Association Class 2 or higher) within 6 months
- •Uncontrolled arrhythmias
- •Stroke within 6 months
- •Inherited retinal degeneration including retinitis pigmentosa
- •Vision loss in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION)
- •Plans to donate blood for at least 6 months after final dose of the investigational products
- •Unwilling to comply with the lifestyle guidelines in the protocol
- •Not eligible due to other reasons at the investigator's discretion
研究组 & 干预措施
Arm 1 AVODART, CIALIS, DKF-313
In Period 1, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose. In Period 2, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose.
干预措施: AVODART (Drug)
Arm 1 AVODART, CIALIS, DKF-313
In Period 1, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose. In Period 2, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose.
干预措施: DKF-313 (Drug)
Arm 1 AVODART, CIALIS, DKF-313
In Period 1, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose. In Period 2, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose.
干预措施: CIALIS (Drug)
Arm 2 DKF-313, AVODART, CIALIS
In Period 1, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose. In Period 2, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose.
干预措施: DKF-313 (Drug)
Arm 2 DKF-313, AVODART, CIALIS
In Period 1, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose. In Period 2, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose.
干预措施: AVODART (Drug)
Arm 2 DKF-313, AVODART, CIALIS
In Period 1, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose. In Period 2, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose.
干预措施: CIALIS (Drug)
结局指标
主要结局
AUClast and Cmax of dutasteride and tadalafil
时间窗: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192 h
次要结局
未报告次要终点