KCT0004038已完成未知
A Randomized, Open-label, Single-dosing, 2-way Crossover Phase 1 Study to Compare and Evaluate Safety and Pharmacokinetic Characteristics after Administration of the KKM-174” or KKM-174-R” in Healthy Male Volunteers
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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. Inclusion Criteria
- •1) Healthy male older than 19 to 45 years at the time of screening
- •2) Body weight more than 50kg and Body Mass Index(BMI) 18.0kg/m2 ~ 30.0 kg/m2
- •? BMI(kg/m2) = Body weight (kg) / {height (m)}2
- •3) Subject should not have congenital/chronic disease or pathological symptoms/findings
- •4) Subject judged to be eligible by clinical laboratory tests such as serum test, hematology test, blood chemistry test, blood coagulation test, urine test, urine drug test, and 12-lead electrocardiogram test were performed according to the characteristics of the drug during the screening test.
- •5) Subject who fully understands the clinical trials after in-depth explanation, volunteers to join the clinical trials and signs inform consent
排除标准
- •2. Exclusion Criteria
- •1) Person with clinically significant liver dysfunction, kidney, digestive system, respiratory system, blood / tumor system, endocrine system, urinary system, neuropsychiatry, musculoskeletal system, immune system
- •? Type 1 diabetes or patients of diabetic ketoacidosis
- •? Patients who have known anaphylactic or anaphylactic hypersensitivity to the drug or its components or who have experienced exfoliative skin disease, including Stevens-Johnson syndrome.
- •? Patients with renal impairment
- •2)Persons with a history of gastrointestinal disorders (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of pharmaceuticals for clinical trials
- •3)Those who have a history of hypersensitivity reaction to clinically significant components or constituents of clinical trial medicines or other clinically significant drugs or additives
- •4)At the screening, 12-lead electrocardiogram with clinically significant findings including the following findings.
- •? QTc > 450 msec
- •? PR interval > 200 msec
- •? QRS duration > 120 msec
- •5)When screening, Thoes whose results of clinical laboratory tests show the following results.
- •? Liver function tests AST, ALT, ALP, ?-GTP and Bilirubin total exceed 2 times the upper limit of normal range
- •? If serum creatinine level exceeds the normal range or eGFR calculated by the Modification of Diet in Renal Disease (MDRD) is less than 60 mL / min / 1.73 m2
- •6)A person who has a history of drug abuse or has been tested positive by a screening test
- •7)At the time of screening, after resting for more than 3 minutes, at the vital sign measured in a sitting position, the systolic blood pressure = 150 mmHg or =90 mmHg or the diastolic blood pressure =100 mmHg or =60 mmHg, pulse = 40 times / min or = 100 times / min.
- •8) Food supplements that may affect abnormal metabolism or metabolism that may affect absorption, distribution, metabolism and excretion of drugs.
- •9)Taking metabolizing enzyme inducers or inhibitors such as barbitals within 30 days before the first administration.
- •10)In the case of taking any special medicines (ETC drugs) or herbal medicines, including cyclosporine, within 2 weeks before the first dosing day, or taking any general medicines (OTC medicines) or vitamin preparations within 1 week, If it is determined that it may affect the test or affect the safety of the testee.
- •11)Those who have participated in other clinical trials or bioequivalence studies within 3 months of the first administration day and administered the clinical trial drug
- •12)One who whole blood donation in two months or apheresis donation in one month before administraing the first Investigational product .
- •13)Drinking continuously (21 units / week, 1 unit = 10 g = 12.5 mL of pure alcohol) within 6 months of the first administration, or one person who can not abstain (250 ml) = 10 g, shochu (20%) 1 glass (50 ml) = 8 g, wine (12%) 1 glass (125 ml) = 12 g)
- •14)Smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 24 hours before dosing to the time of the last blood sampling.
- •15)Grapefruit (grapefruit) containing or consuming food containing grapefruit for 48 hours before the first administration and during PSV until the time of the clinical trial.
- •16)Those who have ingested or can not forcibly consume caffe
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