A Open-label, Single-dose, Phase 1 Study to Compare and Evaluate the Safety and Pharmacokinetics According to the Dose of Camostat Mesylate in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Cmax of GBPA
研究概览
简要总结
Safety and pharmacokinetics evaluation study according to the dose of camostat mesylate in healthy 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 adults aged ≥ 19 and ≤ 55 years at screening
- •Subjects with body weight of ≥ 55.0 kg and ≤ 90.0 kg, and a body mass index (BMI) of ≥ 18.0 and ≤ 29.9
- •Subjects who have no congenital or chronic disease and have no pathological symptoms or findings as a result of an internal examination
排除标准
- •Subjects with current or prior history of a clinically significant hepatic, renal, nervous, respiratory, gastrointestinal, endocrine, hematologic and oncologic, urogenital, cardiovascular, musculoskeletal or psychiatric disorder
- •Subjects with symptoms of acute disease within 28 days prior to the scheduled first administration date of IP
- •Subjects with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcers, etc.) or gastrointestinal resection (except simple appendectomy or hernia surgery) that may affect the absorption of drugs.
研究组 & 干预措施
Cohort 1 (Part 1)
DWJ1248 100mg (100mg 1tab) PO
干预措施: DWJ1248 (Drug)
Cohort 2 (Part 1)
DWJ1248 200mg (100mg 2tab) PO
干预措施: DWJ1248 (Drug)
Cohort 3 (Part 1)
DWJ1248 300mg (100mg 3tab) PO
干预措施: DWJ1248 (Drug)
Group A (Part 2)
DWJ1248 100mg 2tab PO - Wash out - DWJ1248 200mg 1tab PO
干预措施: DWJ1248 (Drug)
Group B (Part 2)
DWJ1248 200mg 1tab PO - Wash out - DWJ1248 100mg 2tab PO
干预措施: DWJ1248 (Drug)
结局指标
主要结局
Cmax of GBPA
时间窗: 0-6 hr
Maximum blood concentration of GBPA (GUANIDINO BENZOYLOXY PHENYLACETIC ACID METHANESULFONATE) among observed blood concentrations at time points * Immediately before administration of IP * After administration
AUClast of GBPA
时间窗: 0-6 hr
Area under the blood concentration-time of GBPA (GUANIDINO BENZOYLOXY PHENYLACETIC ACID METHANESULFONATE) among observed blood concentrations at time points * Immediately before administration of IP * After administration
次要结局
未报告次要终点