NCT03802162已完成1 期
An Open-label, Randomized, Multiple-dosing Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355 With D797 and D324 in Healthy Subjects
适应症
干预措施
相关药物
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
- Cmax of D324
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-355.
详细描述
An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics, safety and tolerability of CKD-355 with D797 and D324 in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 older than 19 years and less than 55 years at the time of screening
- •BMI 18.5~29.9 kg/m2 and body weight more than 50kg
- •Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men
- •Subjects who sign on an informed consent form willingly
排除标准
- •Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.
- •Subjects who have acute disease within 28 days prior to the first administration
- •Subjects who have history that may affect the ADME
- •Subjects who have clinically significant chronic disease
- •Women who are nursing, pregnant or positive on pregnancy test
- •Subjects who have clinically significant allergic diseases
- •Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Subjects who are known to be hypersensitive to the drug or its components
- •Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)
- •Subjects with creatinine clearance <60 ml / min
- •Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range
- •Subjects who taked ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 1 week prior to the first administration
- •Subjects who can not eat standard meals provided by the institution.
- •Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days
- •Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration
- •Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days before the first administration (eg, ingestion of grapefruit juice>1 L / day)
- •Subjects who participate in the other clinical trial within 90 days prior to the first administration
- •Subjects who have a history of regular alcohol(alcohol>210g/week) or caffeine(caffeine>5 cups/day)
- •Subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial
- •Subjects who is determined unsuitable to participate in this clinical trial by the investigator
研究组 & 干预措施
CKD-355A
Experimental
干预措施: CKD-355A (D797/Memantine HCl 20mg) (Drug)
CKD-355B
Experimental
干预措施: CKD-355B (D797/Memantine HCl 20mg) (Drug)
D797, D324
Active Comparator
干预措施: D797 (Drug)
D797, D324
Active Comparator
干预措施: D324 (Memantine HCl 10mg) (Drug)
结局指标
主要结局
Cmax of D324
时间窗: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Max Concentration of D324
AUCt of D797
时间窗: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Area under the curve of D797
AUCt of D324
时间窗: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Area under the curve of D324
Cmax of D797
时间窗: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Max Concentration of D797
次要结局
- Tmax of D324(0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours)
- t½ of D324(0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours)
- Cmin of D797(0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours)
- t½ of D797(0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours)
- Cmin of D324(0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours)
- Tmax of D797(0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours)
研究者
研究点 (1)
Loading locations...
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