A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety After Single/Multiple Administration of CKD-382, D860 and D027 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Primary Pharmacokinetic Endpoint
研究概览
简要总结
to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects
详细描述
A randomized, open-label, crossover phase 1 clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 19 aged and 50 aged in healthy adult
- •Body weight more than 50kg
- •BMI more than 18.0 and under 27.0
- •Who has negative result on Helicobacter Pylori antibody test
排除标准
- •Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease
- •Have a gastrointestinal disease history(including surgery) that can effect drug absorption
- •Hypersensitivity reaction of clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family
研究组 & 干预措施
A
Period 1: CKD-382 Period 2: D860 Period 3: D027
干预措施: CKD-382, D860, D027 (Drug)
B
Period 1: CKD-382 Period 2: D027 Period 3: D860
干预措施: CKD-382, D860, D027 (Drug)
C
Period 1: D860 Period 2: D027 Period 3: CKD-382
干预措施: CKD-382, D860, D027 (Drug)
D
Period 1: D860 Period 2: CKD-382 Period 3: D027
干预措施: CKD-382, D860, D027 (Drug)
E
Period 1: D027 Period 2: D860 Period 3: CKD-382
干预措施: CKD-382, D860, D027 (Drug)
F
Period 1: D027 Period 2: CKD-382 Period 3: D860
干预措施: CKD-382, D860, D027 (Drug)
结局指标
主要结局
Primary Pharmacokinetic Endpoint
时间窗: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
AUCt,ss Evaluation after multiple dose -AUCt,ss: Area under the plasma drug concentration-time curve within a dosing interval in steady-state
Primary Pharmacodynamic Endpoint
时间窗: 24 hours after multiple dose for 7 days compared to baseline
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
次要结局
- (2) Secondary Pharmacokinetic Endpoint(0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours)
- (1) Secondary Pharmacokinetic Endpoint(0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours)
- (1) Secondary Pharmacodynamic Endpoint(24 hours after first dose compared to baseline)
- (2) Secondary Pharmacodynamic Endpoint(24 hours after first dose and multiple dose for 7 days)