KCT0009387已完成Unknown
An open-label, randomized, 2-sequence, 4-period, sinlge-dose, repeated-crossover study to evaluate the pharmacokinetics and the safety of AD-201 compared to coadministration of AD-2011 with AD-2012 in healthy adult volunteers
Addpharma0 个研究点目标入组 58 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) A person who is 19 years of age or older at the time of screening visits
- •2) Those who do not have congenital or chronic diseases during screening visits and have no pathological symptoms or findings as a result of medical examination
- •3) A person who determines that the test manager (or a commissioned test doctor) is suitable for testing as a result of diagnostic tests and electrocardiogram (EKG) such as hematologic tests, blood chemistry tests, urine tests, etc. conducted according to the characteristics of clinical drugs
- •4) Persons with blood pressure as follows
- •· Systolic blood pressure is 90 mmHg or more and 139 mmHg or less
- •· Diastolic blood pressure is 60 mmHg or more and 89 mmHg or less
- •5) Those whose BMI measurement results are 18Kg/m2 or more and 30Kg/m2 or less during screening visits
- •·BMI (Kg/m2) = Weight (Kg)/[Height (m)]2
- •6) A person who has no history of mental illness within five years prior to the date of the screening visit
- •7) A person who has agreed to exclude the possibility of pregnancy by using a medical contraceptive* from the date of first administration of the clinical trial drug to 14 days after the date of last clinical trial drug administration
- •*Contraception: Use a combination of intrauterine devices (IUD, IUS), vasectomy, ovarian ligation and blocking contraception (male condom, female condom, cervical cap, contraceptive septum, sponge, etc.) or use a combination of two or more blocking contraceptives when using a biocidal agent
- •8) A person who has signed a consent form according to his/her free will after hearing and understanding the purpose, contents, characteristics of clinical trial drugs, and expected adverse reactions, etc. of this clinical trial
排除标准
- •1) A person who has a history of gastrointestinal diseases or gastrointestinal resection that may affect the absorption of clinical trial drugs
- •2) In the case of female volunteers, those who are suspected of being pregnant or nursing
- •3) A person who has taken a drug metabolism enzyme-inducing or inhibitory drug, such as barbitale drugs, within one month prior to the start of the trial (the first day of administration)
- •4) A person who has administered a drug (cyclosporin, fibrate, etc.) that may interfere with the test within 10 days before the start of the test (the first day of administration). (But, participation can be made in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with clinical trial drugs and half-life of combined drugs.)
- •5) Excessive alcohol consumption within 1 month prior to the start of the trial (first dosing date)
- •·For women, over 14 cups/week
- •·For men, over 21 cups/week
- •(1 cup = 50mL soju or 30mL liquor or 250mL beer)
- •6) A person who has participated in a clinical trial or biological equivalence test and administered a clinical trial drug within 6 months prior to the trial (the first day of administration)
- •7) A person who has donated whole blood within 2 months (the first day of administration) or donated ingredients within 14 days, or has received blood transfusions within 30 days before the start of the trial
- •8) A person who has a history of clinically significant hypersensitivity or muscle toxicity to the main ingredients and similar families of clinical trial drugs (cholesterol absorption inhibitors, HMG-CoA conversion enzyme inhibitors, angiotensin conversion enzyme inhibitors, angiotensin receptor blockers, etc.) or components
- •9) A person whose blood AST (GOT) or ALT (GPT) level exceeds twice the upper limit of the reference range, or whose ?-GTP level exceeds 1.5 times the upper limit of the reference range
- •10) Moderate renal impairment (eGFR < 60 mL/min)
- •11) Hypothyroidism (TSH > 5.50 µIU/mL in blood)
- •12) A person who has or is likely to develop a genetic muscle disease, myopathy, or rhabdomyolysis
- •13) Patients with hereditary angioedema or who have a history of angioedema when administered angiotensin converting enzyme inhibitors or angiotensin receptor blockers
- •14) Since this drug contains lactose, a person who has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •15) A person who is deemed unsuitable for participation in this clinical trial by the examination manager (or a commissioned examiner) due to other reasons
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