A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers
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-330, D086, CKD-333
研究概览
简要总结
This study is a randomized, open-label, fasted, single dose, crossover study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.
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 14 days.
Reference drug: 1) CKD-330 16/10mg Tab. 2) D086 Tab. Test drug: 1) CKD-333 16/10/40mg formulation 1 Tab. 2) CKD-333 16/10/40mg formulation 2 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •19 to 55 years old healthy subject 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 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 who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
- •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
- •CK > 3x 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 6 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)
- •Patient with hyperkalemia
- •Patients with hepatopathy
- •Patients with hereditary angioedema, ACE inhibitors or angiotensin Ⅱ receptor antagonists who have a history of angioedema
- •Primary hyperaldosteronism
- •Patients with aortic valve stenosis, mitral (valve) stenosis, hypertrophic obstructive cardiomyopathy
- •Patients with ischemic heart disease, ischemic cardiovascular disease, cerebrovascular disease
- •Patients with Intravascular volume depletion
- •Patients with nephropathy (eGFR<60 ml/min/1.73 m2)
- •Patients with renal artery stenosis
- •Patients with muscle disease
- •Patients with Hypothyroidism
- •Women who are pregnant or may be pregnant
- •Patients with a history of muscle toxicity when using statins or fibrates
- •Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- •Individuals who were deemed to be inappropriate to participate in the study by the investigator
研究组 & 干预措施
Group 2
- Period 1: Treatment C
- Period 2: Treatment A
- Period 3: Treatment B
干预措施: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T (Drug)
Group 1
- Period 1: Treatment A
- Period 2: Treatment B
- Period 3: Treatment C
干预措施: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T (Drug)
Group 1
- Period 1: Treatment A
- Period 2: Treatment B
- Period 3: Treatment C
干预措施: CKD-333 16/10/40mg formulation 1 Tab. 1T (Drug)
Group 1
- Period 1: Treatment A
- Period 2: Treatment B
- Period 3: Treatment C
干预措施: CKD-333 16/10/40mg formulation 2 Tab. 1T (Drug)
Group 2
- Period 1: Treatment C
- Period 2: Treatment A
- Period 3: Treatment B
干预措施: CKD-333 16/10/40mg formulation 1 Tab. 1T (Drug)
Group 2
- Period 1: Treatment C
- Period 2: Treatment A
- Period 3: Treatment B
干预措施: CKD-333 16/10/40mg formulation 2 Tab. 1T (Drug)
Group 3
- Period 1: Treatment B
- Period 2: Treatment C
- Period 3: Treatment A
干预措施: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T (Drug)
Group 3
- Period 1: Treatment B
- Period 2: Treatment C
- Period 3: Treatment A
干预措施: CKD-333 16/10/40mg formulation 1 Tab. 1T (Drug)
Group 3
- Period 1: Treatment B
- Period 2: Treatment C
- Period 3: Treatment A
干预措施: CKD-333 16/10/40mg formulation 2 Tab. 1T (Drug)
Group 4
- Period 1: Treatment C
- Period 2: Treatment B
- Period 3: Treatment A
干预措施: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T (Drug)
Group 4
- Period 1: Treatment C
- Period 2: Treatment B
- Period 3: Treatment A
干预措施: CKD-333 16/10/40mg formulation 1 Tab. 1T (Drug)
Group 4
- Period 1: Treatment C
- Period 2: Treatment B
- Period 3: Treatment A
干预措施: CKD-333 16/10/40mg formulation 2 Tab. 1T (Drug)
Group 5
- Period 1: Treatment B
- Period 2: Treatment A
- Period 3: Treatment C
干预措施: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T (Drug)
Group 5
- Period 1: Treatment B
- Period 2: Treatment A
- Period 3: Treatment C
干预措施: CKD-333 16/10/40mg formulation 1 Tab. 1T (Drug)
Group 5
- Period 1: Treatment B
- Period 2: Treatment A
- Period 3: Treatment C
干预措施: CKD-333 16/10/40mg formulation 2 Tab. 1T (Drug)
Group 6
- Period 1: Treatment A
- Period 2: Treatment C
- Period 3: Treatment B
干预措施: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T (Drug)
Group 6
- Period 1: Treatment A
- Period 2: Treatment C
- Period 3: Treatment B
干预措施: CKD-333 16/10/40mg formulation 1 Tab. 1T (Drug)
Group 6
- Period 1: Treatment A
- Period 2: Treatment C
- Period 3: Treatment B
干预措施: CKD-333 16/10/40mg formulation 2 Tab. 1T (Drug)
结局指标
主要结局
Cmax of CKD-330, D086, CKD-333
时间窗: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
The maximum CKD-330/D086/CKD-333 concentration in blood sampling time t
AUCt of CKD-330, D086, CKD-333
时间窗: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Area under the CKD-330/D086/CKD-333 concentration in blood-time curve from zero to final
次要结局
未报告次要终点