KCT0001252招募中未知
A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Assess the Safety and the Pharmacokinetic Characteristics of Lodivikar tab. 5/40 mg in Healthy Adult Male Subjects
Hanlim Pharmaceutical0 个研究点目标入组 32 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 32
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) Years 20-45, healthy male
- •2) Body weight=55kg and IBW=± 20%
- •3) Subject judged suitable by physical examination and interview conducted in accordance with this study protocol
- •4) Subject judged suitable by clinical laboratory tests and ECG
- •5) volunteer
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 known for hypersensitivity reaction to S-amlodipine, amlodipine and olmesartan and dihydropyridine derivatives
- •3) Clinically significant hypotension(SBP=100mmHg, DBP=60mmHg) or hypertension(SBP=150mmHg, DBP=95mmHg) when screening period
- •4) Subject with known for history of gastrointestinal disease or gastrointestinal surgery which affect on the absorption drug
- •5) Subject with any of the following conditions in laboratory test
- •i. AST(sGOT) or ALT(sGPT) > Upper normal limit × 1.5 ii. Total bilirubin > Upper normal limit × 1.5 iii. reanl failure with Creatinine clearance < 50mL/min
- •6) Continued excessive use of caffeine (caffeine > five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette > 10 cigarettes per day)
- •7) Participation in any clinical investigation within 60days prior to study medication dosing
- •8) Subjects with whole blood donation within 60days, component blood donation within 30days
- •9) Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital wihin 28days prior to study medication dosing
- •10) Use of any prescription medication within 14 days prior to study medication dosing or use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
- •11) psychiatric disorder, drug addiction
- •12) Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefluit juice within 14 days prior to study medication dosing
- •13) Subjects 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
研究者
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