NCT05634447已完成1 期
A Phase I Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-391 and Co-administration of CKD-331 and D337 in Healthy Adult Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-391
详细描述
A phase I clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after administration of CKD-391 and co-administration of CKD-331 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult aged between 19 to 55 at screening
- •Weight ≥ 50kg(man) or 45kg(woman), with calculated body mass index (BMI) of 18 to 30kg/m2
- •Those who have no clinically significant congenital or chronic diseases and have no abnormal symptoms of findings
- •Those who are deemed suitable for clinical trials based on laboratory (hematology, blood chemistry, serology, urinalysis, urine drug test) and 12-lead ECG results at screening
- •Those who agree to contraception from the first IP dosing day till 14 days after the last dosing day and decide not to provide sperm during the participation of clinical trial
- •Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial
排除标准
- •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
- •Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 21 glasses/week(man), 14 glasses/week(woman), smoking> 20 cigarettes/day) and not able to stop on smoking, caffeine and alcohol
- •Those who received investigational products or participated in bioequivalence test within 6 months before the first administration of clinical trial drugs
- •Those who donated whole blood within 8 weeks before the first date of administration and donated ingredients within 2 weeks or received blood transfusion in 4 weeks
- •Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery
- •Patients with the following diseases
- •Patients with active liver disease or with elevated amino transferase levels with unknown cause increased by more than 3 times the normal upper limit
- •Patients with severe liver failure or biliary obstruction and bile congestion
- •Patients with muscular disease, rhabdomyolysis, or persons with a past history
- •Patients with hypothyroidism, patients with genetic muscle disease or their family history, and patients with history of muscle disability due to drugs
- •Patients with renal impairment or a history of in and patients with severe renal dysfunction
- •Patients with a history of muscle toxicity to other statin drugs or fibrate drugs
- •Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •Those who have hypersensitivity to the main constituents or components of the investigational drug
- •Those who have a history of drug abuse within 1 year of screening or who have tested positive for urine drug tests
- •Woman who are pregnant or breastfeeding
- •Those who are deemed insufficient to participate in clinical study by investigators
结局指标
主要结局
Primary Outcome Measure
时间窗: Pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hours
AUCt of CKD-391: Area under the concentration-time curve time zero to time
次要结局
未报告次要终点
研究者
研究点 (2)
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