Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUCt of CKD-348
研究概览
简要总结
A clinical trial to compare the pharmacokinetics and tolerability of CKD-348
详细描述
A randomized, open-label, single-dose, 3-way crossover clinical trial to compare the pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult volunteers
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged ≥ 19-year-old
- •Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
- •Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg
- •Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
- •Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
- •Those who agree to contraception during the participation of clinical trial
- •Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
排除标准
- •Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
- •Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
- •Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month
- •Those who has a history of gastrointestinal surgery (
- •Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day
- •Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency
- •Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- •Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
- •Women who are pregnant or who may be pregnant and breastfeed
研究组 & 干预措施
Sequence 2
Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
干预措施: CKD-348 F2 (Drug)
Sequence 3
Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
干预措施: CKD-348 F2 (Drug)
Sequence 1
Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
干预措施: CKD-348 F1 (Drug)
Sequence 1
Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
干预措施: CKD-348 F2 (Drug)
Sequence 1
Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
干预措施: CKD-828, D097, D337 (Drug)
Sequence 2
Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
干预措施: CKD-348 F1 (Drug)
Sequence 2
Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
干预措施: CKD-828, D097, D337 (Drug)
Sequence 3
Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
干预措施: CKD-348 F1 (Drug)
Sequence 3
Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
干预措施: CKD-828, D097, D337 (Drug)
Sequence 4
Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
干预措施: CKD-348 F1 (Drug)
Sequence 4
Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
干预措施: CKD-348 F2 (Drug)
Sequence 4
Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
干预措施: CKD-828, D097, D337 (Drug)
Sequence 5
Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
干预措施: CKD-348 F1 (Drug)
Sequence 5
Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
干预措施: CKD-348 F2 (Drug)
Sequence 5
Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
干预措施: CKD-828, D097, D337 (Drug)
Sequence 6
Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
干预措施: CKD-348 F1 (Drug)
Sequence 6
Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
干预措施: CKD-348 F2 (Drug)
Sequence 6
Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
干预措施: CKD-828, D097, D337 (Drug)
结局指标
主要结局
AUCt of CKD-348
时间窗: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
AUCt: Area under the concentration-time curve from time zero to time
Cmax of CKD-348
时间窗: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Cmax: Maximum plasma concentration of the drug
次要结局
- AUCinf of CKD-348(Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours)
- Tmax of CKD-348(Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours)
- t1/2 of CKD-348(Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours)
- AUCt/AUCinf of CKD-348(Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours)