KCT0002200已完成未知
Repeated dosing clinical trial to assess the pharmacokinetic characteristics and safety/tolerability of HL151 formulation in healthy male subjects
Hanlim Pharmaceutical0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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 in the age of 19-45
- •2. Body weight = 50kg, BMI 18~29 kg/m2
- •3. Subject who sign on an informed consent form willingly
排除标准
- •1. Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- •2. Subject with acute disease within 28 days prior to study medication dosing
- •3. Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
- •4. Subject with clinically significant chronic disease
- •5. Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, Venereal Disease Research Laboratory
- •6. Use of any prescription medication within 14 days prior to study medication dosing
- •7. Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
- •8. Subject with clinically significant allergic disease
- •9. Subject with known for hypersensitivity reaction to bepotastine
- •10. Subject with any of the following conditions in laboratory test
- •a. AST/ALT > UNL (upper normal limit) x 2
- •b. Total bilirubin > UNL x 2
- •c. Renal failure with Creatine clearance < 50mL/min calculated on Cockcroft-Gault [Cockcroft-Gault GFR = (140-age) * (Wt in kg) / (72 *Cr)]
- •d. Systolic Blood Pressure<100mmHg or =160mmHg, Diastolic Blood Pressure><60mmHg or =100mmHg e. QTc>440msec on Electrocardiogram
- •f. Serum potassium < 3.5 mEq/L or > 5.5 mEq/L
- •11. Immunological incompetence, immune deficiency or taking immunosuppressants
- •12. Subject who cannot take standard meal
- •13. Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing
- •14. Subject with blood transfusion within 30days prior to study medication dosing
- •15. Participation in any clinical investigation within 90days prior to study medication dosing
- •16. Continued excessive use of caffeine (caffeine >five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day)
- •17. Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
- •18. Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital wihin 30days prior to study medication dosing
- •19. Subject who are not using adequate means of contraception
- •20. Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption.
- •21.Subject with history of drug abuse or drug addiction
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