KCT0009585已完成Unknown
A randomized, open, single-dose, 2x2 crossover-design clinical trial to evaluate the safety and pharmacokinetic characteristics after co-administration of AD-2021 and AD-2022 or administration of AD-202 in healthy volunteers
Addpharma0 个研究点目标入组 60 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
- 60
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 45(Year)（—）
- 性别
- All
入选标准
- •1) Healthy adults over 19 and under 45 at the time of screening tests
- •2) Subjects with a weight of 50 kg or more and a calculated BMI in the range of 18.5 to 29.9 kg/?
- •3) Subjects who have agreed to use medically recognized appropriate contraception and not to provide sperm from the first day of clinical trial drug administration to the 28th day after the last day of administration
- •- Spousal (or partner) tubal resection and ligation
- •- vasectomy
- •- Double contraception: Combining condoms for men with other contraceptives (or oral contraceptives, intrauterine devices (loop, mirna), physical blockages (femidoms for women), subcutaneous transplant contraception (such as implanone), and Jihyo contraceptives or emergency contraceptives
- •4) Subjects who have fully understood after hearing the detailed explanation of this clinical trial and have voluntarily decided to participate and agreed in writing to comply with the precautions
排除标准
- •1) A person with a clinically significant history or manifestation of liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood, tumor, urinary system, cardiovascular system, musculoskeletal disease or mental illness
- •2) Subjects with clinically significant active chronic diseases
- •3) Subjects with acute disease symptoms within 28 days of first administration
- •4) Persons with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcers, etc.) or gastrointestinal resection (except simple appendectomy or hernia) that may affect the absorption of drugs
- •5) Subjects with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose uptake disorder, or a history of genetic muscle disease or family history
- •6) Subjects with clinically significant allergic diseases (However, mild allergic rhinitis and allergic dermatitis that do not require administration can be selected)
- •7) Subjects who have hypersensitivity reactions to drugs or other drugs (aspirin, antibiotics, etc.) containing the following drugs or components of the same class, have a history of clinical significant hypersensitivity reactions, have a history of substance abuse, or have a positive urine drug test
- •- CCB drugs
- •- HMG-CoA inhibitor series drugs
- •- Ezetimibe
- •8) Subjects with one or more of the following results in a screening test, including a reexamination
- •- AST, ALT > UNL (upper normal limit) x 2.0
- •- If the level of creatine in the blood exceeds the reference range or the eGFR calculated by the Modification of Diet in Renal Disease (MDRD) formula is less than 60 ml/min/1.73?
- •- Electrocardiography shows QTc exceeding 450 msec
- •- CPK > UNL (upper normal limit) x 5
- •- Serum K >5.5 mEq/L
- •- clinically significant hemoglobin (Hb) abnormal
- •9) Subjects whose blood pressure falls within the following range in the examination conducted during the screening visit
- •- Systolic blood pressure: below 100 mmHg or above 159 mmHg
- •- Diastolic blood pressure: below 60 mmHg or above 99 mmHg
- •10) Subjects who test positive for RPR Ab, anti-HIV (AIDS), HBs Ag, and HCV Ab
- •11) Subjects who received prescription drugs (ETC) within 14 days of the first administration date
- •12) Subjects who received over-the-counter medicines (OTC), including herbal medicines, within 7 days of the first administration date
- •13) If there is a history of hypothyroidism or a clinically significant test value or higher
- •14) A person who has donated whole blood within 60 days before the first administration of a clinical drug, donated ingredients within 30 days, or received a blood transfusion within 30 days
- •15) A person who has participated in a clinical trial or biological equivalence test for another drug within six months prior to the first administration of a drug for clinical trials. (However, the criteria for completion of participation in other clinical trials are based on the last administration date.)
- •16) A person who has taken a drug metabolism enzyme induction and inhibitory drug, such as barbitale drugs, within 30 days prior to the first administration date
- •17) A person who has consumed more than 5 cup/day of grapefruit juice or caffeine within 3 months of screening, or who is forced to consume it during the clinical trial period
- •18) Those who exceeded the alcohol consumption of 21 units/week (1 unit = 10 g = 12.5 ml of pure alcohol) within 3 months of screening or who cannot abstain from drinking during the entire clini
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