KCT0008216招募中未知
Phase 1 study to evaluate the food effect on the safety and the pharmacokinetics of UI061 in he althy volunteers
Korea United Pharm0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 24
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) Those aged 19 years or older at the time of screening visit
- •2) Those who weighed more than 60 kg and had a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less at the screening visit? BMI (kg/m2) = weight (kg)/{height (m)}2
- •3) Those who have no clinically significant congenital or chronic diseases and no pathological symptoms or findings as a result of internal medical examination at the screening visit
- •4) Those who are determined to be suitable by diagnosis tests such as hematology test, blood chemistry test, serum test, urine test, etc. and electrocardiogram test, which are set and conducted by the principal investigator (or the delegated sub-investigator)
- •5) From the first administration of the investigational product until 7 weeks after the last administration of the investigational products, the person, spouse, or partner agrees to exclude the possibility of pregnancy by using a contraceptive method* recognized in clinical trials and does not provide sperm or eggs who agreed to
- •* Recognized methods of contraception in clinical trials: Combination of intrauterine device, vasectomy, tubal ligation and blocking contraception (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or two methods when using spermicide Use of multiple barrier methods of contraception
- •6) Those who voluntarily signed a written informed consent form after receiving and understanding sufficient explanations about the purpose and contents of this clinical trial, the characteristics of the investigational product, and expected adverse reactions, etc.
排除标准
- •1) Persons with clinically significant diseases or history of the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary reproductive system, mental and nervous system, musculoskeletal system, immune system, otolaryngology, skin system, and ophthalmology.
- •2) Those with a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect drug absorption or gastrointestinal disease
- •3) Those who have taken drug metabolism enzymes, such as barbiturate drugs, within one month of the first administration date or who have taken drugs that may interfere with this clinical trial within 10 days of the first dose date
- •4) Those who have administered investigational drugs by participating in other clinical trials or bioequivalence studies within 6 months of the first administration date
- •5) A person who has donated whole blood within 8 weeks of the date of first administration, or has donated components within 2 weeks, or has received a blood transfusion within 4 weeks
- •6) Those who meet the following conditions within 1 month of the first administration date
- •For men, average alcohol consumption exceeding 21 drinks/week
- •For women, average alcohol consumption exceeding 14 drinks/week
- •(1 glass = Soju 50mL or Western liquor 30mL or Beer 250mL)
- •Smoking more than 20 cigarettes per day on average
- •7) Those who fall under the following
- •Patients with hypersensitivity to investigational drugs or components contained in investigational drugs
- •Those with a history of hypersensitivity to biguanide drugs
- •8) Patients with the following diseases
- •Patients with moderate (stage3b) and severe renal impairment (eGFR <45mL/min/1.73m2), acute conditions that may affect renal function such as dehydration, serious infection, cardiovascular collapse (shock), acute myocardial infarction, and sepsis
- •Patients with acute and unstable heart failure
- •Patients undergoing examinations in which radioactive iodine contrast material is administered intravenously (e.g., intravenous urography, intravenous cholangiography, angiography, computed tomography using a contrast agent, etc.)
- •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
- •· Diabetes mellitus
- •· Patients with severe infectious disease or severe traumatic systemic disorder
- •Patients with malnutrition, starvation, weakness, pituitary insufficiency or adrenal insufficiency
- •Patients with acute or chronic diseases that can cause tissue hypoxia, such as liver dysfunction, respiratory failure, acute myocardial infarction, and shock, excessive alcohol consumption, and gastrointestinal disorders such as dehydration, diarrhea, and vomiting
- •9) A person who is judged unsuitable for participation in this clinical trial by the principal investigator (or the delegated sub-investigator) for reasons other than the above selection/exclusion criteria
- •10) For female volunteers, those who are pregnant or suspected of being pregnant or are breastfeeding
研究者
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