KCT0007757已完成未知
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic characteristics and safety of KD4002 in healthy volunteers under fasting conditions
Kyung Dong Pharmaceutical0 个研究点目标入组 40 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
- 40
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 o Limit（—）
- 性别
- All
入选标准
- •1. Healthy adults 19 years of age or older at the time of screening
- •2. BMI : 17.5 kg/m2 more than, 30.5 kg/m2 less than. Male : 55 kg more than / Female : 45 more than
- •3. Those who have no congenital or chronic diseases within the last 3 years and no pathological symptoms or findings as a result of medical examination
- •4. Those who are judged to be suitable as test subjects as a result of screening tests conducted by the investigator according to the characteristics of the drug (hematology, blood chemistry, urinalysis, virus/bacterial test, etc.), vital signs, electrocardiogram, etc.
- •5. Those who have the ability and willingness to participate during the entire examination period
排除标准
- •1. Those who have a history or evidence of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological, or immune disease (except for simple dental history such as calculus, impacted tooth, wisdom tooth)
- •2. Those who have a history of gastrointestinal diseases (esophageal diseases such as achalasia or esophageal stricture, Crohn's disease) or surgery (except simple appendicectomy, hernia surgery, and tooth extraction) that may affect drug absorption
- •3. A person who shows the following values ??as a result of laboratory tests
- •: ALT or AST - twice the upper limit of the normal range
- •4. Those with a history of regular alcohol intake exceeding 210 g/week within 6 months of screening
- •5. Those who have taken other investigational drugs or bioequivalence investigational drugs within 6 months prior to the first administration of the clinical investigational drug
- •6. Those with a history of serious alcohol or drug abuse within 1 year of screening
- •7. A person who has taken a drug known to significantly induce or inhibit drug metabolizing enzymes within 30 days before the first administration of the clinical trial drug
- •8. Smokers who smoked more than 20 cigarettes a day within 6 months of screening
- •9. Those who have taken prescription or non-prescription drugs within 10 days prior to the first administration of clinical investigational drugs
- •10. Those who have donated whole blood within 2 months before the first administration of the clinical investigational drug, or donated component blood within 1 month
- •11. Persons with severe acute/chronic medical or mental conditions that may increase the risk due to administration of investigational drugs and participation in the trial or may interfere with the interpretation of trial results
- •12. Patients with moderate (stage3b) and severe renal impairment (eGFR <45 ml/min/1.73 m2). Kidney disease or renal insufficiency that may result from conditions such as cardiovascular collapse (shock), acute myocardial infarction and sepsis ) patient
- •13. Patients with congestive heart failure who require medication
- •14. Patients undergoing an intravenous administration of radioiodine contrast material
- •15. Patients with acute or chronic metabolic acidosis including type 1 diabetes mellitus, lactic acidosis, diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis
- •16. diabetic coma
- •17. Patients with a history of hypersensitivity to components of investigational drugs or biguanides
- •18. Patients who exercise vigorously
- •19. Patients with malnutrition, starvation, weakness, pituitary insufficiency or adrenal insufficiency
- •20. Women who are pregnant or may be pregnant, or lactating women
- •21. Others judged by the investigator as inappropriate to participate in this study
研究者
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