An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-386(2) With Co-administration of D013, D326, and D337 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUCt of CKD-386(2)
研究概览
简要总结
A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-386(2)
详细描述
An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-386(2) with co-administration of D013, D326, and D337 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 —（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 ≥50kg (man) or 45kg (woman), 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 12-lead ECG 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 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 4 weeks.
- •Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
- •Those who exceed an alcohol and cigarette consumption than below criteria
- •Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
- •Heavy Smoking: 20 cigarettes/day
- •Patients with the following diseases
- •Patients with hypersensitivity to the main constituents or components of the investigational drug
- •Severe hepatic impairment, biliary atresia or cholestasis
- •Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists
- •Diabetes mellitus
- •Patients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2]
- •Renal vascular hypertension patients
- •Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit
- •Patients with myopathy or have a history of family or genetic history of myopathy
- •Hypothyroidism
- •If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs
- •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 study by investigators.
- •Woman who are pregnant or breastfeeding.
研究组 & 干预措施
Sequence 1
Period 1: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-386(2)- A single oral dose of 1 tablet under fasting condition Period 3: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 4: CKD-386(2)- A single oral dose of 1 tablet under fasting condition
干预措施: CKD-386(2) (Drug)
Sequence 1
Period 1: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-386(2)- A single oral dose of 1 tablet under fasting condition Period 3: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 4: CKD-386(2)- A single oral dose of 1 tablet under fasting condition
干预措施: D013, D326, D337 (Drug)
Sequence 2
Period 1: CKD-386(2)- A single oral dose of 1 tablet under fasting condition Period 2: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-386(2)- A single oral dose of 1 tablet under fasting condition Period 4: D013, D326, D337- A single oral dose of 3 tablets under fasting condition
干预措施: CKD-386(2) (Drug)
Sequence 2
Period 1: CKD-386(2)- A single oral dose of 1 tablet under fasting condition Period 2: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-386(2)- A single oral dose of 1 tablet under fasting condition Period 4: D013, D326, D337- A single oral dose of 3 tablets under fasting condition
干预措施: D013, D326, D337 (Drug)
结局指标
主要结局
AUCt of CKD-386(2)
时间窗: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Area under the concentration-time curve from time zero to time
Cmax of CKD-386(2)
时间窗: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Maximum plasma concentration of the drug
次要结局
- Tmax of CKD-386(2)(Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours)
- T1/2 of CKD-386(2)(Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours)
- AUCinf of CKD-386(2)(Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours)
- AUCt/AUCinf of CKD-386(2)(Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours)