NCT05544214已完成1 期
An Open Label, Randomized, Single Dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cmax of CKD-371, D745+D759
研究概览
简要总结
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects
详细描述
To healthy 32 subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: D745, D759 / Test drug: CKD-371
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults volunteers aged between 19 and 45 years old at the time of screening
- •Weight ≥50kg, with calculated body mass index (BMI) of 18.0 to 29.9 kg/m2 at the time of screening
- •Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial
排除标准
- •Those with clinically significant diseases or history in cardiovascular system, respiratory system, liver, kidney, hematological, gastrointestinal, endocrine system, immune system, skin system, mental/nervous system, etc
- •Those who have symptoms of acute disease within 28 days of the the first dose of the investigational product
- •Those who with a history of influencing drug absorption, distribution, metabolism, and excretion
- •Those who have a hypersensitivity reaction or a history of clinically significant hypersensitivity reaction or a history of drug abuse inculding SGLT2 inhibitor class component or DPP 4 inhibitor class or same class component drugs containing ingredients
- •Those with clinically significant active chronic disease
- •Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption
- •A person who has had one or more of the following results in screening tests including re-examination
- •AST, ALT > UNL (upper normal limit) x 2.5
- •Fasting glucose < 70 mg/dL
- •Calculated by Cockcroft Gault formula Creatinine clearance is 75mL/min or less (Cockcroft Gault GFR = (140 age) * (Wt in kg) / (72 * Cr))
- •QTc > 470 msec as a result of ECG
- •Urine-hCG test is positive(if it is limited to female subjects)
- •Those who test positive for HBs Ag, HCV Ab, HIV Ab, or VDRL
- •Those who have taken prescription medicine (ETCs), including prescription drugs, within 14 days of the first dose
- •Those who have taken over-the-counter medicines (OTC) including herbal medicines within 7 days of the first dose
- •Clinically significant allergic diseases, mild allergic rhinitis that do not require medication, and allergic dermatitis can be selected
- •Those who cannot eat the standard meal provided by the institution
- •Those who donated whole blood within 60 days prior to the first dose or donated component blood within 20 days
- •Those who received a blood transfusion within 30 days prior to the first dose
- •Those who have participated in other clinical studies or bioequivalence studies within 6 months of the first dose and administered the investigational drug
- •Those who had taken any drug known as a strong inducer or inhibitor of drug-metabolizing enzymes within 30 days prior to the first dose of the investigational product
- •Those who have continuously consumed grapefruit juice or caffeine > 5 cups a day, or cannot refrain from intake during hospitalization
- •Consistently drinking alcohol > 30 days or unable to abstain from alcohol during hospitalization
- •Excessive smokers > 20 cigarettes non-daily or unable to quit smoking during hospitalization
- •Pregnant or childbearing potential and lactating women
- •Those who consent to the use of reliable contraception(contraceptive methods other than hormones: use of condoms, intrauterine devices (IUD, IUS), tubal ligation, cervical cap, contraceptive diaphragm, etc.) during the clinical trial and not to donate sperm until 2 month after the last administration of investigational product
- •Clinical laboratory test results and other reasons eg, a person who does not respond to requests and instructions, or who judges the investigator to be inappropriate to participate in the clinical trial with a non-cooperative attitude
研究组 & 干预措施
Sequence 1
Experimental
Period 1 - A single dose of 2 tablets(D745, D759) under fasting condition.
Period 2 - A single dose of 1 tablets(CKD-371) under fasting condition.
干预措施: CKD-371 (Drug)
Sequence 2
Experimental
Period 1 - A single dose of 1 tablets(CKD-371) under fasting condition.
Period 2 - A single dose of 2 tablets(D745, D759) under fasting condition.
干预措施: CKD-371 (Drug)
结局指标
主要结局
Cmax of CKD-371, D745+D759
时间窗: Pre-dose(0hr), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48hr
The maximum CKD-388/D418 concentration in blood sampling time
AUCt of CKD-371, D745+D759
时间窗: Pre-dose(0hr), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48hr
Area under the CKD-371, D745+D759 concentration in blood-time curve from zero to final
次要结局
未报告次要终点
研究者
研究点 (1)
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