KCT0004026已完成未知
A study to evaluate the pharmacokinetics and safety of KD4004 after oral administration in healthy adult volunteers
Kyung Dong Pharmaceutical0 个研究点目标入组 80 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
- 80
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) Adults who are at least 19 years old at the time of screening
- •2) Those who have a body mass index (BMI) of 18.0 kg / m2 or more and 29.9 kg / m2 or less at screening
- •3) Patients with no congenital or chronic disease and no medically symptomatic findings
- •4) Those who are determined to be eligible for the results of 12-lead electrocardiogram and clinical tests such as serum test, hematology test, blood chemistry test, urine test, etc., set by the doctor in charge within 3 weeks prior to administration of the drug for clinical trial
- •5) ? ????? ?? ??? ??? ?? ??? ??? ?, ??? ??? ???? ????? ????? ?? ??? ?
排除标准
- •1) Persons who have a history of hypersensitivity reactions or other clinically significant hypersensitivity to other drugs or additives in the main components or components of clinical trial medicines
- •2) There is a clinically significant liver / biliary system, kidney, respiratory system, digestive system, blood • tumor, endocrine system, cardiovascular system, nervous system, skin and urinary system, mental illness, A person with
- •3) Diabetic patients (diabetic patients with history of ketoacidosis), diabetic ketoacidosis, lactic acidosis, pre-diabetic comatose patients or those with a history of diabetes
- •4) Patients who received intravenous administration of radiation iodine contrast material (intravenous urography, intravenous cholangiography, angiography, computed tomography using contrast media, etc.) within one week before the first dosing day
- •5) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •6) In a vital sign measured in a sitting position, a person having a numerical value included in any one of the criteria of systolic blood pressure = 140 mmHg or <90 mmHg, diastolic blood pressure =95 mmHg, or <60 mmHg, pulse rate> 100 times / minute
- •7) Patients with active liver disease or those with AST, ALT, or total bilirubin greater than 1.5 times the upper limit of normal range
- •8) Creatinine clearance <80 mL / min (creatinine clearance is calculated by Cockcroft-Gault formula using serum creatinine)
- •9) Patients who have gastrointestinal diseases (Crohn's disease, active peptic ulcer, etc.) that may affect the absorption of clinical trial medications or gastrointestinal surgery (except for simple cecal surgery or hernia surgery)
- •10) Any person who has suffered a major injury within 4 weeks prior to the first dose, or who has undergone surgical procedures and who has suspected acute illness (severe infectious disease, severe trauma, severe diarrhea, vomiting, etc.)
- •11) (Cigarettes> 10 cfu / day) who are unable to abstain during the clinical trial from 3 days prior to the clinical trial, or those who are unable to continue drinking during the trial (21units / week, 1unit = 10g = 12.5mL of pure alcohol)
- •12) Those with a history of substance abuse
- •13) From the screening date until 30 days after the last clinical trial drug administration, appropriate double-pregnancy or medically acceptable contraceptive methods (including intrauterine devices with proven pregnancy failure rates, physical contraceptive methods and spermicide) Use, vasectomy, tubal resection / ligation, hysterectomy, etc.)
- •14) Women who are pregnant or who may be pregnant and breastfeeding
- •15) Any person taking any OTC medicines or herbal medicines within 2 weeks of the first day of medication or who has taken any OTC medication within 1 week will be subject to the judgment of the examiner that the medication will affect the test or the safety of the subject When it is judged to be influential
- •16) Those who participated in other clinical trials within 3 months before the first dosing day (The time of ending the previous clinical test is set as the last dosing day.)
- •17) Those who donated whole blood within 2 months before the first administration day, or those who donated blood within 1 month
- •18) Those who received blood transfusions within one month before the first dose
- •19) Those who have had abnormal diets that can affect the absorption, distribution, metabolism and excretion of the
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