NCT04478097Unknown1 期
A Randomized, Open, Single-dose, 3 Period Partial Replicated Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-333 or Co-administration of CKD-330 and D086 in Healthy Volunteers Under Fasting Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- AUCt of CKD-330, D086, CKD-333
研究概览
简要总结
This study is a randomized, open, single-dose, 3 period partial replicated crossover-design study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.
详细描述
To healthy subjects of fifty-one (51), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.
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 adults over the age of 19 years and under the age of 55 years at the time of screening
- •Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 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 following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed at screening
- •Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation
- •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 the entire study period
排除标准
- •Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
- •Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
- •Individuals with the following results at screening test:
- •ALT or AST > 2x the upper limit of the normal range
- •Creatinine > upper limit of the normal range or eGFR with MDRD <60 ml/min/1.73 m2
- •ECG Result, QTc > 450msec
- •CPK > UNL(upper normal limit) x 3.0
- •K > 5.5mEq/l
- •Hct < lower limit of the normal range
- •A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first dose to end of last blooding (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 or cannot quit smoking during hospitalization period
- •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
- •Following vital signs results at screening
- •Sitting systolic blood pressure ≥ 140 mmHg or < 90 mmHg
- •sitting diastolic blood pressure ≥90 mmHg or <60 mmHg
- •Individuals with a medical history of significant drug abuse within one year prior to the screening or positive for abuse drug in urine test results at screening
- •Individuals taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days before the first administration of clinical trial drug
- •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 hypersensitivity to investigational products or the investigational products ingredients
- •Patients or conditions deemed to be at risk for using investigational products
- •Patient with hyperkalemia
- •Patients with hepatopathy
- •Patients with hereditary angioedema, ACE inhibitors or angiotensin 2 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 diabetes or kidney failure
- •Patients with renal artery stenosis
- •Patients with muscle disease
- •Patients with Hypothyroidism
- •Patients with a history of muscle toxicity when using statins or fibrates
- •Patients who have recently had a kidney transplant
- •Patients with history of shock
- •Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- •Individuals who drunk grapefruit juice or caffeine more than 5 cup per day within 3 months prior to screening or cannot quit drinking during clinical trials period
- •Individuals who cannot eat standard meal in institution
- •Women who are pregnant or may be pregnant
- •Individuals who were deemed to be inappropriate to participate in the study by the investigator
研究组 & 干预措施
Test-Reference-Reference
Experimental
干预措施: CKD-330 Tab. and D086 Tab. (Drug)
Reference-Reference-Test
Experimental
干预措施: CKD-330 Tab. and D086 Tab. (Drug)
Reference-Reference-Test
Experimental
干预措施: CKD-333 Tab. (Drug)
Reference-Test-Reference
Experimental
干预措施: CKD-330 Tab. and D086 Tab. (Drug)
Reference-Test-Reference
Experimental
干预措施: CKD-333 Tab. (Drug)
Test-Reference-Reference
Experimental
干预措施: CKD-333 Tab. (Drug)
结局指标
主要结局
AUCt of CKD-330, D086, CKD-333
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, 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
Cmax of CKD-330, D086, CKD-333
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, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
The maximum CKD-330/D086/CKD-333 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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