KCT0006661招募中未知
A randomized, open-label, multiple doses, crossover clinical study to compare the pharmacokinetic characteristics and the safety between administration of EL-1804 and co-administration of EL-1804R-1 and EL-1804R-2 in healthy adult subjects
Elyson Pharmaceutical0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 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 55?(Year)（—）
- 性别
- All
入选标准
- •1) Healthy adult subject`s age 19~55 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 test
- •5) Subject 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 IRB
排除标准
- •1) Subjects who have clinically significant or a history of cardiovascular, respiratory, hepatic, kidneys, neurological, endocrine, blood, psychiatric or urinary diseases
- •2) Subjects who have a histroy of gastrointestinal disease or gastrointerstinal 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 hisptory of hypersensitivity or clinically significant hypersensitivity to drugs containing the active ingredients or components of the IP or other drugs such as asprin, antibiotics, etc.
- •5) Subjects who show hypotension(SBP<90mmHg) or hypertension(SBP>150mmHg or DBP>95mmHg) at the screening
- •6) Subjects with following results;
- •- AST or ALT > 2 times upper limit of normal range
- •- Total bilirubin > 2.0mg/mL
- •- eGFR < 60mL/min/1.73m2
- •7) Subjects who drink continously(more than 21units/week, 1unit=10g=12.5mL of per alcohol) or who can`t drink during the clinical trial period
- •8) Subjects who continue to smoke(more than 10 cigarattes/day) or who can`t smoke during the hospritalization for the clinical trial period
- •9) Subjects who take the medication involved in other clincal trials or bioequivalence study within 6 months before the first administration day
- •10) Subjects who have donated whole blood within 60 days, or a component blood donation within 30 days or received blood transfusion within 30 days before the first administration day
- •11) Subjects who have taken any prescription or herbal medicine within 14 days or any OTC within 7 days before the first administration day
- •12) Subjects who have taken drug metabolizing enzyme-inducing and suppressing drugs such as barbital drugs within 1 month before first administration day
- •13) Subjects who have a diet(pariculary grapefruit juice or its products) within 7 days prior to the first administration day that may affect the absorption, distribution, metabolism and excretion of the drug
- •14) Subjects who don`t agree to exclude the possibility of pregnacy using a medicaly recongmized contraceptive method from the first administration day to 7 days after the last administration of the IP
- •15) A mental patient, and a drug addict
- •16) Subjects who are unwilling or unable to comply to diet and lifestyle required in the clinical trial
- •17) Subjects who have clinically significant abnormalities as a result of other clinical laboratory tests or who judged the persion in charge of clinical trial to be ineligible for participation in the clinical trial due to other reasons such as non-compliance of instruction, uncooperative attitude, and others
- •18) Positive finding in pregnant or serum/urine hCG test, or lactating women
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