KCT0003304进行中（未招募）未知
A randomized, open-label, single-dosing, 2x2 crossover study to compare the safety and pharmacokinetics of UI014 tablet with UIC201606 under fed conditions in healthy male volunteers.
Korea United Pharm0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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. Healthy male, between 19-45 of age.
- •2. Total body weight is at least 55 kg and within 20% of ideal body weight.
- •3. No morbid conditions or findings under medical examinations. No congenital disorders or chronic diseases.
- •4. Abnormal laboratody tests judged clinically significant.
- •5. Volunteers should read, sign, and date an informed consent form priort to any study procedures.
排除标准
- •1. Clinically significant present illnesses or past histories.
- •2. Gastrointestinal disorders affecting the absorption of investigational drugs.
- •3. Allergic reations to any ingredient of investigation products or allgergic reactions to derivatives.
- •4. Galactose intolerance, Lapp lactose deficiency, or glucose-galactose malansorption.
- •5. Systolic blood pressure >= 140 mmHg,< 90 mmHg, or diastolic blood pressure >= 95 mmHg, <60 mmHg, or pulse rate >= 100 bpm.
- •6. Impared hepatic function or gallbladder disorders.
- •7. Impared renal function.
- •8. Alanine aminotransferase is equal to or more than 100 IU/L.
- •9. Creatinine clearance is less than 30 mL/min.
- •10. Drug abuse.
- •11. CYP inducers or inhinitors like barbital within 1 month prior to the administration of investigational products.
- •12. Heavy drinkings within 1 month prior to the administration of investigational products.
- •13. Taking prescription medications or herbal herbal medicines within 2 weeks prior to the administration of investigational products.
- •14. Taking OTC drugs or OTC vitamins within 10 days prior to the administration of investigational products.
- •15. Using any investigationa drug within 3 months prior to the administration of investigational products.
- •16. Whole blood donation within 2 months prior to the administration of investigational products.
- •17. Apheresis within 1 month prior to the administration of investigational products.
- •18. alcohol abuse over 21 units per week.
- •19. Subjects unwilling or unable to comply with the alcohol restriction during the hospitalization.
- •20. smoking over 10 cigarettes per day within recent 3 months.
- •21. Subjects considered ineligible by investigators.
- •22. Unable to use appropriate contraception during the study.
研究者
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