NCT03858725已完成1 期
A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteer
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
- 36
- 试验地点
- 1
- 主要终点
- Cmax of CKD-374 and D569
研究概览
简要总结
This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-374 5 mg in healthy volunteers.
详细描述
To healthy subjects of thirty-six (36), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: D569 Tab. / Test drug: CKD-374 5mg Tab. Pharmacokinetic blood samples are collected up to 12hrs. 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 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject older than 19 years and less than 55 years at the screening
- •Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and a total body weight ≥ 55 kg
- •* BMI = Weight(kg)/ Height(m)2
- •Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
- •Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG, chest X-ray etc.)
- •Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational drug
- •Individuals with the ability and willingness to participate during the study period
排除标准
- •Individuals with a medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease (excluding simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
- •Individuals with a medical history of gastrointestinal disease (e.g., gullet disease including esophageal achalasia, esophagostenosis, or Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction surgery) that may affect drug absorption
- •Individuals with the following laboratory test results: ALT or AST > 2x the upper limit of the normal range
- •A history of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
- •Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening
- •Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 3 months prior to the first dose of this study
- •Individuals with the following vital signs results at screening
- •*Individuals who had sitting blood pressure ≥90 mmHg or <140 mmHg (systolic) or ≥90 mmHg or <60 mmHg (diastolic)
- •Individuals with a medical history of significant alcohol abuse or drug abuse within one year prior to the screening
- •Individuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s)
- •Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
- •Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
- •Individuals with severe acute/chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results
- •Individuals with hypersensitivity to ingredients used in the investigational product(s)
- •Patients with serious infection (e.g., Sepsis) or active infection including localized infection or history of interstitial pneumonia
- •Patients with active tuberculosis or history of tuberculosis
- •Patients with hepatopathy
- •Patients with an absolute neutrophil count (ANC) less than 1000 /ul
- •Patients with an absolute lymphocyte count (ALC) less than 500 /ul
- •Patients who have hemoglobin levels less than 9 g/dL
- •Women who are pregnant or may be pregnant
- •Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- •Patients with nephropathy (eGFR<60 ml/min/1.73 m2)
- •Individuals who were deemed to be inappropriate to participate in the study by the investigator
研究组 & 干预措施
D569/CKD-374 5mg
Experimental
- Period 1: D569 Tab. 1T
- Period 2: CKD-374 5mg Tab. 1T
干预措施: D569 Tab. (Drug)
D569/CKD-374 5mg
Experimental
- Period 1: D569 Tab. 1T
- Period 2: CKD-374 5mg Tab. 1T
干预措施: CKD-374 5mg Tab. (Drug)
CKD-374 5mg/D569
Experimental
- Period 1: CKD-374 5mg Tab. 1T
- Period 2: D569 Tab. 1T
干预措施: D569 Tab. (Drug)
CKD-374 5mg/D569
Experimental
- Period 1: CKD-374 5mg Tab. 1T
- Period 2: D569 Tab. 1T
干预措施: CKD-374 5mg Tab. (Drug)
结局指标
主要结局
Cmax of CKD-374 and D569
时间窗: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours]
The maximum CKD-374/ D569 concentration in blood sampling time t
AUCt of CKD-374 and D569
时间窗: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours]
Area under the CKD-374/ D569 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)
Loading locations...
相似试验
已完成
1 期
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 in Healthy VolunteersCardiovascular DiseasesNCT04075643Chong Kun Dang Pharmaceutical52
Unknown
1 期
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-389Type 2 DiabetesNCT04322032Chong Kun Dang Pharmaceutical34
已完成
1 期
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy VolunteersDyslipidemiasHypertensionNCT04019743Chong Kun Dang Pharmaceutical24
已完成
1 期
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy SubjectsDiabetes Mellitus, Type 2NCT04260438Chong Kun Dang Pharmaceutical24
已完成
1 期
Study to Evaluate the Bioequivalence of Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy VolunteersRheumatoid ArthritisNCT03868072Chong Kun Dang Pharmaceutical40