KCT0003451已完成未知
An open-label and single-dosing study to evaluate the safety, pharmacokinetics and food effect of UI026 in healthy male volunteers.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 12
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
- 19(Year) 至 45(Year)（—）
- 性别
- Male
入选标准
- •1.A healthy adult male aged between 19 and 45 years old at the time of the screening test
- •2.[IBW (kg) = (height (cm) -100) × 0.9], which is within the range of ± 20% of the calculated ideal body weight (IBW)
- •3.Patients without congenital or chronic disease and no medical findings or symptoms
- •4.Hematology test, blood chemistry test, urine test, etc. Clinical laboratory test result is judged to be suitable as the subject
- •5.Those who have given full explanation of the clinical trial and agreed in writing to fully understand and then decide to participate voluntarily
排除标准
- •1. Patients with clinically significant liver, kidney, nervous system, respiratory, hematologic, neurological, psychiatric, cardiovascular and endocrine disorders or who have a history
- •2. Patients with a history of gastrointestinal disorders (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of clinical trial medications
- •3. Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to components of the clinical trial drug and similar drugs
- •4. Those with a history of substance abuse
- •5. Those who take drugs or induce excessive metabolism of drugs, such as barbiturates, within 1 month before the first dosing day
- •6. (OTC drug) or vitamin preparation within 1 week of the first dose within 10 days prior to the first administration day
- •7. Those who participated in other clinical studies or bioequivalence studies within 3 months of the first administration day and administered the clinical trial drug
- •8. A person who has received a whole blood donation within 2 months before the first administration date or a component blood donation within 1 month, or who received a transfusion within 1 month before the first administration day
- •9. Those who are continuously drinking (21 units / week, 1 unit = 10 g of pure alcohol) or who can not abstain from discharge 24 hours before discharge
- •10. Those who have been smoking within 3 months of screening
- •11. A person who is found to be unsuitable for clinical trial participation due to other reasons including clinical laboratory test results
- •12. Those who show the following figures
- •- Hemoglobin <12.0 g / dL
- •- Serum AST or ALT> 2 times the upper limit of normal
- •- Total bilirubin in blood> 2 times the upper limit of normal
研究者
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