NCT04676893Unknown1 期
An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- AUCt of CKD-388, D418
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 subjects of fifty-six (56), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.
Reference drug: D418 Tab. / Test drug: CKD-388 Tab. Pharmacokinetic blood samples are collected up to 72hrs. 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 male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.
- •Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2
- •* BMI = Weight(kg)/ Height(m)2
- •Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of Investigational Product (IP) administration
- •Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical tail
排除标准
- •History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
- •With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
- •Any medical history that may affect drug absorption, distribution, metabolism and excretion.
- •Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse
- •Thiazolidinedione
- •DPP-4 inhibitor
- •Metformin
- •Any clinically significant chronic medical illness.
- •Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •Individuals with one of the following laboratory test results in screening
- •AST, ALT > UNL (upper normal limit) x 3
- •Creatinine clearance ≤ 80 mL/min
- •In ECG result, QTc > 450 msec
- •hCG(+) (only women)
- •Individuals who had positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
- •Use of any prescription drugs within 14 days prior to study drug administration.
- •Use of over-the-counter medications and herbal preparations within 7 days prior to study drug administration.
- •History of any clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not required medication may be allowed).
- •Individuals who cannot eat standard meal provided from clinical trial center.
- •Donation of blood within 60 days prior to study drug administration or apheresis within 20 days prior to the first IP administration.
- •Individuals who had received a blood transfusion within 30 days prior to study drug administration.
- •Exposure to any investigational drug within 6 months prior to the first IP administration.
- •Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
- •Individuals who had consumed grapefruit juice > 5cups/day or caffeine > 5cups/day within 30 days prior to the first IP administration or who cannot stopping consume grapefruit juice or caffeine during clinical study.
- •Individuals who had drinking (alcohol > 30 g/day) within 30 days prior to the first IP administration or who cannot stop drinking.
- •Heavy smoking (more than 10 cigarettes/day) within 30 days prior to screening or who cannot quit smoking during clinical study.
- •Pregnant or women who may be pregnant
- •Subjects having been deemed inappropriate for the trial as determined by the investigator.
研究组 & 干预措施
Reference-Test
Experimental
干预措施: D418 Tab. (Drug)
Reference-Test
Experimental
干预措施: CKD-388 Tab. (Drug)
Test-Reference
Experimental
干预措施: D418 Tab. (Drug)
Test-Reference
Experimental
干预措施: CKD-388 Tab. (Drug)
结局指标
主要结局
AUCt of CKD-388, D418
时间窗: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
Area under the CKD-388/D418 concentration in blood-time curve from zero to final
Cmax of CKD-388, D418
时间窗: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
The maximum CKD-388/D418 concentration in blood sampling time t
次要结局
未报告次要终点
研究者
研究点 (1)
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