A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics 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
- 32
- 试验地点
- 1
- 主要终点
- AUCt of CKD-348(4) F1 and CKD-348(4) F2
研究概览
简要总结
A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged ≥ 19 years
- •Weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2
- •Those who meet the 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 diseases or chronic diseases and have no abnormal symptoms or findings.
- •Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 1ECG results at screening.
- •Those who agree to contraception during the participation of clinical trial.
- •Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
排除标准
- •Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- •Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.
- •Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
- •Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
- •Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.
- •Alcohol: Man - 21 glasses/week Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
- •Smoking: 20 cigarettes/day
- •Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism.
- •Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- •Those who are deemed insufficient to participate in this clinical trial by investigators.
- •Woman who are pregnant or breastfeeding.
研究组 & 干预措施
Sequence 1
Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-348(4) F1 (Drug)
Sequence 1
Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-348(4) F2 (Drug)
Sequence 1
Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition
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 condition Period 2: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-348(4) F1 (Drug)
Sequence 2
Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-348(4) F2 (Drug)
Sequence 2
Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-828, D097, D337 (Drug)
Sequence 3
Period 1: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-348(4) F1 (Drug)
Sequence 3
Period 1: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-348(4) F2 (Drug)
Sequence 3
Period 1: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-828, D097, D337 (Drug)
Sequence 4
Period 1: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition
干预措施: CKD-348(4) F1 (Drug)
Sequence 4
Period 1: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition
干预措施: CKD-348(4) F2 (Drug)
Sequence 4
Period 1: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition
干预措施: CKD-828, D097, D337 (Drug)
Sequence 5
Period 1: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-348(4) F1 (Drug)
Sequence 5
Period 1: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-348(4) F2 (Drug)
Sequence 5
Period 1: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-828, D097, D337 (Drug)
Sequence 6
Period 1: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition
干预措施: CKD-348(4) F1 (Drug)
Sequence 6
Period 1: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition
干预措施: CKD-348(4) F2 (Drug)
Sequence 6
Period 1: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition
干预措施: CKD-828, D097, D337 (Drug)
结局指标
主要结局
AUCt of CKD-348(4) F1 and CKD-348(4) F2
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(4) F1 and CKD-348(4) F2
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
Maximum plasma concentration of the drug
次要结局
未报告次要终点