KCT0000999已完成未知
Open Label, Randomized, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Lobeglitazone and Warfarin in Healthy Subjects
Chong Kun Dang0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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 55(Year)（—）
- 性别
- Male
入选标准
- •1) A healthy male volunteer between 19 and 55 years old.
- •2) BMI between 19 and 27.
- •3) Signed the informed consent form prior to study participation.
- •4) Able to participate in the entire trial
排除标准
- •1) Clinically significant hepatic, renal, digestive system, respiratory system, endocrine system, nervous system, hematologic, cardiovascular system, tumor or have history of tumor
- •2) Clinically significant hemorrhagic disease
- •3) Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •4) Have hypersensitivity reactions history for lobeglitazone, warfarin, excipient of IP or aspirin, antibiotics
- •5) Medication which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products within 30 days prior to screening
- •6) Participated in the other clinical trials and administrated IP within 60 days prior to screening
- •7) Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before screening
- •8) Previously donate whole blood within 60 days or component blood within 30 days
- •9) sit SBP < 90mmHg or sit SBP = 140mmHg or sit DBP < 60mmHg or sit DBP = 90mmHg
- •10) A heavy alcohol consumer (alcohol > 140 g/week) or cannot stop drinking
- •11) A heavy smoker (cigarette > 10 cigarettes per day) or cannot stop smoking
- •12) A heavy caffeine consumer (more than 4cups per a day) or A heavy grapefruit consumer (more than 1cup per a day) or cannot stop having
- •13)Positive for the Triage TOX drug on urine
- •14) Positive for HIV antibody, HBsAg, HCV antibody test
- •15) AST, ALT or Total bilirubin > UNL * 1.5
- •16) Estimated GFR < normal limit
- •17) INR, aPTT over the normal limit
- •18) Clinically significant laboratory test result
- •19) Clinically significant ECG
- •20) An impossible one who participates in clinical trial by investigator's decision including other reason
研究者
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