An Open-label, Randomized, Fed, Single Dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax of CKD-501, D759, D150, CKD-393
研究概览
简要总结
This study is an open-label, randomized, fed, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-393 in healthy subjects
详细描述
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: 1) CKD-501 0.5mg 2) D759 3) D150 Test drug: 1) CKD-393 0.5/100/1000mg formulation Ⅰ Tab. 2) CKD-393 0.5/100/1000mg formulation Ⅱ Tab.
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 male volunteers, aged between ≥ 19 and ≤ 55 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
- •Subject who consents to use at least two clinically effective birth controls for at least 1 month following the last dose.
- •Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written.
排除标准
- •History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic 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
- •fasting glucose < 70 mg/dL or > 125 mg/dL
- •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 stopping drink.
- •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
Group 1
- Period 1: Treatment A
- Period 2: Treatment B
- Period 3: Treatment C
干预措施: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T (Drug)
Group 1
- Period 1: Treatment A
- Period 2: Treatment B
- Period 3: Treatment C
干预措施: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T (Drug)
Group 1
- Period 1: Treatment A
- Period 2: Treatment B
- Period 3: Treatment C
干预措施: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T (Drug)
Group 2
- Period 1: Treatment A
- Period 2: Treatment C
- Period 3: Treatment B
干预措施: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T (Drug)
Group 2
- Period 1: Treatment A
- Period 2: Treatment C
- Period 3: Treatment B
干预措施: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T (Drug)
Group 2
- Period 1: Treatment A
- Period 2: Treatment C
- Period 3: Treatment B
干预措施: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T (Drug)
Group 3
- Period 1: Treatment B
- Period 2: Treatment A
- Period 3: Treatment C
干预措施: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T (Drug)
Group 3
- Period 1: Treatment B
- Period 2: Treatment A
- Period 3: Treatment C
干预措施: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T (Drug)
Group 3
- Period 1: Treatment B
- Period 2: Treatment A
- Period 3: Treatment C
干预措施: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T (Drug)
Group 4
- Period 1: Treatment B
- Period 2: Treatment C
- Period 3: Treatment A
干预措施: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T (Drug)
Group 4
- Period 1: Treatment B
- Period 2: Treatment C
- Period 3: Treatment A
干预措施: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T (Drug)
Group 4
- Period 1: Treatment B
- Period 2: Treatment C
- Period 3: Treatment A
干预措施: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T (Drug)
Group 5
- Period 1: Treatment C
- Period 2: Treatment A
- Period 3: Treatment B
干预措施: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T (Drug)
Group 5
- Period 1: Treatment C
- Period 2: Treatment A
- Period 3: Treatment B
干预措施: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T (Drug)
Group 5
- Period 1: Treatment C
- Period 2: Treatment A
- Period 3: Treatment B
干预措施: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T (Drug)
Group 6
- Period 1: Treatment C
- Period 2: Treatment B
- Period 3: Treatment A
干预措施: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T (Drug)
Group 6
- Period 1: Treatment C
- Period 2: Treatment B
- Period 3: Treatment A
干预措施: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T (Drug)
Group 6
- Period 1: Treatment C
- Period 2: Treatment B
- Period 3: Treatment A
干预措施: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T (Drug)
结局指标
主要结局
Cmax of CKD-501, D759, D150, CKD-393
时间窗: Time Frame: 0 hour ~ 48 hours
The maximum CKD-501/D759/D150/CKD-393 concentration in blood sampling time t
AUCt of CKD-501, D759, D150, CKD-393
时间窗: Time Frame: 0 hour ~ 48 hours
Area under the CKD-501/D759/D150/CKD-393 concentration in blood-time curve from zero to final
次要结局
未报告次要终点