NCT05698043已完成1 期
An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and the Tolerability of CKD-386(5) With Co-administration of D013, D326, and D337 in Healthy Adult Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- AUCt of CKD-386(5)
研究概览
简要总结
A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-386(5)
详细描述
An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and the tolerability of CKD-386(5) 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 ≥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 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 have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs)
- •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
Experimental
- Period 1: D013, D326, D337- A single oral dose of 3 tablets under fasting condition
- Period 2: CKD-386(5)- A single oral dose of 1 tablet under fasting condition
- Period 3: D013, D326, D337- A single oral dose of 3tablets under fasting condition
- Period 4: CKD-386(5)- A single oral dose of 1 tablet under fasting condition
干预措施: CKD-386(5) (Drug)
Sequence 1
Experimental
- Period 1: D013, D326, D337- A single oral dose of 3 tablets under fasting condition
- Period 2: CKD-386(5)- A single oral dose of 1 tablet under fasting condition
- Period 3: D013, D326, D337- A single oral dose of 3tablets under fasting condition
- Period 4: CKD-386(5)- A single oral dose of 1 tablet under fasting condition
干预措施: D013, D326, D337 (Drug)
Sequence 2
Experimental
- Period 1: CKD-386(5)- 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(5)- 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(5) (Drug)
Sequence 2
Experimental
- Period 1: CKD-386(5)- 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(5)- 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(5)
时间窗: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours
Area under the concentration-time curve from time zero to time
Cmax of CKD-386(5)
时间窗: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours
Maximum plasma concentration of the drug
次要结局
未报告次要终点
研究者
研究点 (1)
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