An Open Label, Randomized, Single Dose, Crossover, Phase I Study to Evaluate the Pharmacokinetics and the Safety of D311 and D107 Compared to CKD-339 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- AUCt of CKD-339
研究概览
简要总结
This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-339 in healthy volunteers.
详细描述
To 76 healthy subjects, following treatments, are administered dosing in each period and wash-out period is 14 days.
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
- •Healthy adults between the age of 19 and 55 (inclusive) at the time of screening test.
- •Subjects with a body mass index(BMI) between 18 and 30 kg/m2(BMI = Weight(kg)/ Height(m)2)
- •Male subjects weighing at least 50 kg
- •Female subjects weighing at least 45 kg
- •Subjects who do not have clinically meaningful congenital or chronic diseases and who do not have medical examination results (such as electroencephalogram, electrocardiogram, chest and gastroscopy or gastrointestinal radiography, if necessary) during screening visits.
- •Subjects judged by investigators to be suitable for screening tests based on laboratory tests (e.g., blood tests, urine tests) and ECG, which were conducted according to the characteristics of the IP.
- •Subjects who voluntarily signed and dated the informed consent form after fully understanding its contents.
- •Subjects who had agreed to use medically appropriate contraceptive methods* to exclude the possibility of pregnancy from the first dose of the IP to 14 days after the last dose, and not to donate sperm or ovum.
- •contraceptive methods: Combination use of intrauterine device (IUD) or system (IUS), vasectomy, tubal ligation, tubal occlusion and barrier methods of contraception (male condoms, female condoms, cervical caps, contraceptive diaphragm, sponges, etc.) or the use of combined spermicide, involves the simultaneous use of two or more barrier methods.
排除标准
- •Subjects who have taken a drug metabolase-inducing and inhibiting drug such as barbitals within one month prior to the first dosing date or a drug that may interfere with this test within 10 days prior to the first dose of IP.
- •Subjects who had been administered investigational product from other clinical study or bioequivalence study within the 6 months prior to the first dose of IP.
- •Subjects who donated whole blood within 8 weeks, or blood components within 2 weeks prior to the first dose of IP.
- •Subjects who have a history of gastrointestinal resection that may affect the absorption of drugs.
- •Subjects with a history of regular alcohol consumption meeting any of the following criteria within 1 month prior to the first dose of IP.
- •Man: average alcohol consumption > 21 cups/weeks
- •Woman: average alcohol consumption > 14 cups/weeks
- •Patients with the following conditions
- •Patients who have a history of hypersensitivity to main or component of clinical trial drugs and other dihydropyridine drugs
- •Patients on angiotensin converting enzyme (ACE) inhibitor or not more than 36 hours after discontinuation of administration
- •Patients with a history of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor antagonists (ARB) administration
- •Patients with hereditary or idiopathic angioedema
- •Patients with severe liver failure, cirrhosis or biliary obstruction, bile congestion
- •Patients with diabetes or moderate to severe renal impairment (eGFR < 60mL/min/1.73m2) who have been co-administered with alliskyrene
- •Patients with primary aldosteronism
- •Shock patients (including cardiac shock)
- •Patients with severe aortic valve stenosis
- •Patients with unstable angina
- •Patients within one month of the onset of myocardial infarction
- •Subjects with a history of psychiatric disorders.
- •Subjects who are considered unsuitable for participation in this bioequivalence study by the Investigator (or delegated Sub-investigator) for reasons other than the inclusion and exclusion criteria listed above.
- •Female subjects who are pregnant, suspected of being pregnant, or breastfeeding.
研究组 & 干预措施
Sequence A(Reference-Test)
Period 1: A single oral dose of 2 tablets under fasting condition(D311, D107), Period 2: A single oral dose of 1 tablet under fasting condition(CKD-339)
干预措施: CKD-339 (Drug)
Sequence A(Reference-Test)
Period 1: A single oral dose of 2 tablets under fasting condition(D311, D107), Period 2: A single oral dose of 1 tablet under fasting condition(CKD-339)
干预措施: D311, D107 (Drug)
Sequence B(Test-Reference)
Period 1: A single oral dose of 1 tablet under fasting condition(CKD-339), Period 2: A single oral dose of 2 tablets under fasting condition(D311, D107)
干预措施: CKD-339 (Drug)
Sequence B(Test-Reference)
Period 1: A single oral dose of 1 tablet under fasting condition(CKD-339), Period 2: A single oral dose of 2 tablets under fasting condition(D311, D107)
干预措施: D311, D107 (Drug)
结局指标
主要结局
AUCt of CKD-339
时间窗: From 0 to 72 hours postdose
Area under the plasma CKD-339 concentration-time curve from 0 to t
Cmax of CKD-339
时间窗: From 0 to 72 hours postdose
The maximum concentration of CKD-339 in plasma
次要结局
未报告次要终点