KCT0000117已完成未知
Clinical trial to investigate the influence of drug interaction after oral administration of tamsulosin and SK3530 in healthy male volunteers
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 50(Year)（—）
- 性别
- Male
入选标准
- •1. Healthy male adults aged 20 ~ 50 at screening
- •2. Weight = 55 kg and ±20% of ideal body weight
- •? ideal body weight - (height cm - 100) x 0.9
- •3. Signed the informed consent after understanding explanation of the clinical trial
排除标准
- •1. Clinically significant history or current hypersensitivity to SK3530, tamsulosin, or other drug (aspirin, antibiotics)
- •2. Past or current medical history for the diseases in hepatobiliary, renal, nervous, respiratory, endocrinologic, hemato-oncologic, psycologic, ophthalmic or cardiovascular systems including disorders in blood coagulation3. Past medical history of gastrointestinal disease or sugery which can affect the absorption of the investigational drug (except for an simple appendectomy, hernia repair surgery)
- •4. Clinical laboratory test at screening ? AST, ALT > (upper limit of normal reference range)x 1.25
- •5. Vital signs in supine position at screening ? low blood pressures (SBP = 90 mmHg or DBP = 60 mmHg) or high blood pressures (SBP = 140 mmHg or DBP = 90 mmHg)
- •6. Decreased blood pressures over 20 mmHg of SBP or 10 mmHg of DBP at 2 and 4 minutes after standing from supine position
- •7. QTc interval over 430 ms
- •8. A history of drug abuse or a positive result on urine drug testing
- •9. Administered any prescription drug or herbal medicine within 2 weeks prior to the first administration day, or administered any over-the-counter drug or vitamin agent within 1 week before the first administration (however, such a subject can be included when investigators so determined after considering other conditions)
- •10. Participated in another clinical study within 2 months prior to first administration
- •11. Donated whole blood within 2 months prior to the first administration, apheresis within 1 month prior to the first administration
- •12. Chronic alcohol consumer (over 21 units/week, 1 unit = 10 g of pure alcohol) or inable to stop drinking during the study
- •13. Heavy smoker (average : 10 pieces of cigarettes per day)
- •14. Anyone taking food with graphfruits or caffein, drinking alcohol, or smoking from 3 days prior to the first administration of each period (-9 d, 6 d) to the day of dischage (2 d, 16 d)
- •15. Determined to be inappropriate for the study based on laboratory tests or other reasons
研究者
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