NCT04075643已完成1 期
A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 in Healthy Volunteers
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
- 52
- 试验地点
- 1
- 主要终点
- AUCt(Area Under Curve last)
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-385 in healthy volunteers.
详细描述
To healthy subjects of fifty-two (52), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D935 Test drug: CKD-385 Pharmacokinetic blood samples are collected up to 48 hrs. 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult aged over 19 at the time of screening
- •Subject who had 17.5kg/m² ≤ Body Mass Index (BMI) < 30.5kg/m² and a total body weight ≥ 55 kg
- •☞ BMI=Weight(kg) / Height(m)²
- •Subject without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
- •Subject who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
- •Subject who signed an informed consent form approved by the Institutional Review Board(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
- •Subject with the ability and willingness to participate during the study period
排除标准
- •Subject who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases
- •Subject with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug
- •Subject who shows the following values as a result of laboratory tests
- •*Alanine Transaminase(ALT) or Aspartate Transaminase(AST) > 2 times upper limit of normal range
- •Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months prior to screening
- •Subject who smokes more than 20 cigarettes a day within 6 months prior to screening
- •Subject who took other clinical trial drugs or bioequivalence test drugs within 6 months before the first administration of clinical trial drug
- •Subject who conform to the specific items below
- •systolic blood pressure less than 90 mmHg, not less than 140 mmHg or diastolic blood pressure less than 60 mmHg or not less than 90 mmHg in a sitting position
- •Severe bradycardia (less than 50 beats/minute)
- •Subject who has a medical history of significant alcohol abuse or drug abuse within one year prior to screening
- •Subject 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 administration of investigational product(s).
- •Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of investigational product(s).
- •Subject who donated whole blood within 2 months, or blood components within 1 month prior to first administration of investigational product(s).
- •Subject who has hypersensitivity to investigational product(s) or investigational product(s) ingredient.
- •Subject who does not consent to reliable contraception during the entire period of clinical trial and until 7 days after the last administration of investigational product.
- •Subject who were deemed to be inappropriate to participate in the study by the investigator.
研究组 & 干预措施
Group 1
Experimental
- Period 1: Reference drug
- Period 2: Test drug
干预措施: Reference drug (Drug)
Group 1
Experimental
- Period 1: Reference drug
- Period 2: Test drug
干预措施: Test drug (Drug)
Group 2
Experimental
- Period 1: Test drug
- Period 2: Reference drug
干预措施: Reference drug (Drug)
Group 2
Experimental
- Period 1: Test drug
- Period 2: Reference drug
干预措施: Test drug (Drug)
结局指标
主要结局
AUCt(Area Under Curve last)
时间窗: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Area under the plasma concentration time curve of CKD-385/D935, from time zero up to the last measurable concentration.
Cmax
时间窗: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
The maximum concentration observed of CKD-385/D935 over blood sampling time.
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-374 5 mg in Healthy VolunteersRheumatoid ArthritisNCT03858725Chong Kun Dang Pharmaceutical36
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