KCT0004396已完成未知
The phase 1 study to evaluate the pharmacokinetic drug-drug interaction and safety between EL-1804R-1 and EL-1804R-2 in healthy male volunteers
Elyson 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 50?(Year)（—）
- 性别
- All
入选标准
- •1) Healthy male subject’s age 19~50 years at screening
- •2) BMI 18.0-29.0kg/m2 and weight more than 50kg
- •3) Subject who don't have congenital or chronic diseases and have no abnormal medical examination results
- •4) Suitable subject who is determined by ECG and laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug at screening
- •5) Subjects who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by INHA University Hospital IRB
- •6) Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures
排除标准
- •1) Subjects who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- •2) Subjects who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
- •3) Subjects with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •4) SUbjects with a history of hypersensitivity or clinically significant hypersensitivity to drugs or other drugs containing the active ingredients or components of the IP
- •5) Subjects who show hypotension (Systolic Blood Pressure < 90mmHg), hypertension (SBP =150mmHg) or Diastolic Blood Pressure = 95 mmHg at screening
- •6) Subjects with the following results;
- •- AST or ALT > 2 times upper limit of normal range
- •- Total billuribin > 2.0mg/mL
- •- eGFR < 60 mL/min/1.73m2
- •7) Subjects who drink continuosly (more than 21 units/week, 1 unit = 10g = 12.5mL of pure alcohol) or who can`t drink during the study period
- •8) Subjects who continue to smoke (more than 10 cigarettes/day) or who can`t smoke during the hospitalization period
- •9) Subjects who take the medication involved in other clinical trials or bioequivalence test within 6 months before the first dose medication characters
- •10) Subjects who have donated whole blood within 60 days, or a component blood donation within 30 days or received blood transfustion within 30 days before the first adminitration day
- •11) Subjects who have taken any prescription or herbal medicine within 14 days or any OTC within 7 days before the first adminitration day
- •12) Subjects who have taken drug metabolizing enzyme-inducing and suppressing drugs, such as barbital drugs within 1 month before the start of the study
- •13) Meantal illness, drug addict
- •14) Subjects who have a diet (particularly grapefruit juice or its products) within 7 days prior to the first administration date that may affect the absorption, distribution, metabolism and excretion of the drug
- •15) Subjects who do not agree to exclude the possibility of pregnacy using a medicaly recongmized contraceptive method from the first administration of the IP to the 7 day after the last administration of the IP
- •16) Subjects who have clinically significant abnormalities as a result of other clinical laboratory tests or who judged the person in charge of study to be ineligible for participation in the study due to other reasons (eg., non-compliance of instruction, uncooperative attidude, etc.)
- •17) Positivie findings in pregnant or serum/urine hCG tests, or lactating women
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