KCT0001363已完成未知
A Randomized, Open-label, Single-dose, Four-sequence, Four -period Crossover Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas in Healthy Male Volunteers
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 36
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 45(Year)（—）
- 性别
- Male
入选标准
- •1. 20~45 years old, Healthy Adult Male Subject
- •2. Body Weight = 50kg and Ideal Body Weight = ±20%
- •3. Do not have any disease or symptoms which is clinically significant
- •4. Acceptable physical examination and clinical examination, during screening
- •5. Provision of signed written informed consent confirmed IRB
排除标准
- •1. A subject with a history of tamslosin hypersensitivity reaction or clinically significant hypersensitivity reaction
- •2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease
- •3. A subject with a history of gastrointestinal disease(crohn's disease, Ulcer) or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- •4. Unacceptable physical examination and clinical examination, during screening within 28 days prior to the participation in clinical trials
- •5. someone who has a result
- •- ALT or AST > 1.25 times (Upper Normal Range)
- •- Total Bilirubin > 1.5 times (Upper Normal Range)
- •6. Systolic BP >160 mmHg or < 80 mmHg, Diastolic BP >100 mmHg or < 50 mmHg
- •7. someone who has a history of drug abuse or misuse
- •- alcohol abuse is consumption exceeding 21 units/week
- •8. someone who hsa taken a Investigator Product from other trial within 3 months before Investigator Product first medication
- •9. Investigator Product first dose before significant induction or that person taking drugs known to inhibit drug-metabolizing enzymes within 1 month
- •10. someone who has taken other Ethical drugs or herbal medicine within 2 weeks, over the counter drugs or vitamins medicine within 1 week
- •11. someone who has taken abnormal meals like which can affect to Absorption, Distribution, Metabolism , Excretion
- •12. Blood donation during 2 months or apheresis during 1 month before the study
- •13. galactose intolerance, Lapp lactose deficiency someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •14. Use of tobacco in excess of the equivalent of 10 cigarettes per day
- •15. someone who has taken positive result of HBsAg, HCV Ab, HIV Ab
- •16. Judged to be inappropriate for the study by the investigator after reviewing other reasons
研究者
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