NCT06281132已完成1 期
A Randomized, Open-label, Single Dose, 4-period Replicate Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-341 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
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- area under curve(AUC) of CKD-341, D956
研究概览
简要总结
The objective was to evaluate and compare the pharmacokinetic profiles and safety after administration of test drug (CKD-341) and reference drugs (D956) in healthy adults.
详细描述
A randomized, open-label, single dose, 4-period replicate crossover study in healthy adults under fasting conditions
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
- •Healthy adults aged between 19 to 55 years at the time of screening.
- •Individuals who had 18.0 kg/m2 ≤ Body Mass Index (BMI) < 30.5 kg/m2 and whose body weight was ≥ 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 according to the laboratory tests (hematology, blood chemistry, urinalysis, serology, etc.), vital signs, 12-lead electrocardiogram (ECG), etc., performed at screening.
- •Individuals who signed an informed consent form approved by the Institutional Review Board (IRB) of Jeonbuk National University Hospital and who decided to participate voluntarily in the study after being fully informed of the study objective, contents, etc. prior to participation.
- •Individuals who consented to the use of reliable contraception (contraceptive methods other than hormones: use of condoms, intrauterine devices (IUD, IUS), tubal ligation, cervical cap, contraceptive diaphragm, etc.) during the clinical trial and not to donate sperm until 1 month after the last administration of investigational product(s).
- •Individuals with the ability and willingness to participate the entire study period.
排除标准
- •Individuals with medical evidence or a history (excluding a simple dental history of dental calculus, impacted tooth, wisdom tooth, etc.) of clinically significant hematological, renal, endocrine, respiratory, gastrointestinal(Active gastric ulcer), duodenal ulcer, etc.), urinary, cardiovascular (severe aortic valve stenosis, aArterial valve, mitral valve stenosis, obstructive hypertrophic cardiomyopathy, etc.), hepatic (severe hepatic impairment, etc.), psychiatric, neurologic, or immune diseases.
- •Individuals with a medical history of gastrointestinal diseases (e.g., esophageal disorders such as esophageal achalasia or esophagostenosis, Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction) that may affect drug absorption.
- •Individuals with the following laboratory test result at screening:
- •ALT or AST > 2x the upper limit of the normal range
- •CK > 3x the upper limit of the normal range
- •eGFR <60 mL/min/1.73 m2 using CKD-EPI formula
- •Individuals with a history of regular alcohol consumption exceeding 210 g/week within 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 taken investigational product(s) from other clinical trials or bioequivalence studies within 6 months prior to the first administration of the investigational product(s).
- •Individuals with the following vital signs upon screening
- •☞ Systolic blood pressure ≥140 mmHg or <90 mmHg and/or a diastolic blood pressure ≥90 mmHg or <60 mmHg in sitting position.
- •Individuals with a medical history of significant alcohol or drug abuse within 1 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 administration of the investigational product(s).
- •Individuals who had taken prescription or nonprescription drugs within 10 days prior to the first administration of the investigational product(s).
- •Individuals who donated whole blood within 2 months or blood components within 1 month or have given blood transfusion within 1 month prior to the first administration of the investigational product(s).
- •Individuals with severe acute/chronic medical or psychological conditions, whose participation in the clinical trial and administration of the investigational products could increase the risk to the subjects or interfere with the interpretation of trial results.
- •Individuals with hypersensitivity to the investigational product(s), components of the investigational product(s), or dihydropyridine drugs, thiazide diuretics, or sulfonamide drugs, or hereditary issues of intolerance etc.
- •Patients with hereditary angioedema or with a history of angioedema when treated with ACE inhibitors or angiotensin II receptor antagonists.
- •Patients with shock.
- •Patients with anuria.
- •Patients with biliary obstructive disease.
- •Patients with diabetes or moderate to severe renal impairment who use aliskiren-containing preparations in combination.
- •Patients with severe heart failure.
- •Patients with Hypokalemia.
- •Patients with hyponatremia, hypercalcemia.
- •Patients with Hyperuricemia (with gout or uric acid stone).
- •Patients with Addison's syndrome.
- •Patients receiving lithium therapy.
- •Patients taking terfenadine or astemizole (can cause QT prolongation and ventricular arrhythmias).
- •Women who are pregnant or lactating.
- •Individuals who were deemed inappropriate to participate in the study by the investigator.
研究组 & 干预措施
Sequence 1
Experimental
- Period 1: D956
- Period 2: CKD-341
- Period 3: D956
- Period 4: CKD-341
干预措施: CKD-341, D956 (Drug)
Sequence 2
Experimental
- Period 1: CKD-341
- Period 2: D956
- Period 3: CKD-341
- Period 4: D956
干预措施: CKD-341, D956 (Drug)
结局指标
主要结局
area under curve(AUC) of CKD-341, D956
时间窗: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours
Area under the CKD-341, D958 concentration in blood-time curve from zero to
Cmax of CKD-341, D956
时间窗: Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours
The maximum CKD-341, D956 concentration in blood sampling time
次要结局
未报告次要终点
研究者
研究点 (1)
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