NCT02645890已完成1 期
A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Profiles of CKD-397 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
- 36
- 试验地点
- 1
- 主要终点
- AUC0-t of Tadalafil/ Tamsulosin
研究概览
简要总结
The purpose of this study is to compare the safety and pharmacokinetics profiles of CKD-397 in healthy male volunteers.
详细描述
A randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the safety and pharmacokinetic profiles of CKD-397 in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •More than 19 years in Healthy male volunteer
- •Body weight ≥ 55kg and in the range of calculated BMI 17.5 to 30.5kg/m2
- •Subject who signed on an informed consent form willingly
排除标准
- •Clinically significant disease with hematological, nephrological, respiratory, gastrointestinal, urogenital, cardiovascular, psychiatric, neurologic system and allergic disease (except for non-symptom seasonal allergy)
- •Gastrointestinal disease(esophageal achalasia, esophagus stenosis, crohn's disease) or gastrointestinal surgery(except for appendectomy or herniotomy)
- •Aspartate aminotransferase, Alanine aminotransferase > 2 X upper limit of normal range or eGFR which is calculated by MDRD(Modification of diet in renal disease) < 60mL/min/1.73m2
- •Continuously taking excessive alcohol(>210g/week) within 6 months before screening
- •Have received any other investigational drug within 3 months prior to the first dosing
- •Sitting systolic blood pressure ≤ 100mmHg or ≥ 150mmHg, sitting diastolic blood pressure ≤ 60mmHg or ≥ 100mmHg
- •Subject with orthostatic hypotension
- •The history of drug abuse or drug abuse showed a positive for urine drug test
- •Subject who takes inducers or inhibitors of drug metabolizing enzyme within 30 days
- •Cigarette ≥ 20 cigarettes a day for recent 3 months and Subject who cannot stop smoking during clinical trial participation
- •Subject who takes ethical drug or herbal medicine within 2 weeks or over-the-counter drug or vitamins within 1 week
- •Whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing
- •Subject who can increase risk due to clinical test and administration of drugs or has severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
- •Subject with taking any forms of organic nitrate periodically and/or intermittently.
- •Subject with known hereditary degenerative retinal disease including retinitis pigmentosa.
- •Subject with serious history of hypersensitivity to investigational product (including Tadalafil and Tamsulosin) and other medicine (aspirin, antibiotics and so on)
- •Subject who lost sight of one eye by non-arteritic anterior ischemic optic neuropathy (NAION, non-arteritic anterior ischemic optic neuropathy).
- •Subject with genetic problems such as galactose intolerance, fructose intolerance, lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
- •Subject who planned pregnancy during clinical trial and doesn't use trustworthy contraception
- •Subjects who is not able to comply with guidelines described in the protocol.
- •An impossible one who participants in clinical trials by investigator's decision including laboratory test result or another reason
研究组 & 干预措施
CKD-397
Active Comparator
Tadalafil/ Tamsulosin Fixed dose combination
干预措施: CKD-397 (Drug)
TD+TM
Experimental
Tadalafil/ Tamsulosin Coadministration
干预措施: TD+TM (Drug)
结局指标
主要结局
AUC0-t of Tadalafil/ Tamsulosin
时间窗: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
次要结局
- Vd/F of Tadalafil/ Tamsulosin(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours)
- Cmax of Tadalafil/ Tamsulosin(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours)
- AUCinf of Tadalafil/ Tamsulosin(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours)
- Tmax of Tadalafil/ Tamsulosin(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours)
- t1/2 of Tadalafil/ Tamsulosin(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours)
- CL/F of Tadalafil/ Tamsulosin(0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours)
研究者
研究点 (1)
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