NCT05804279已完成1 期
Pharmacokinetics and Safety of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults. Randomized, Open-label, Single-dose, Cross-over, Phase 1 Study
Hyundai Pharm1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年12月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax of memantine and donpezil
研究概览
简要总结
Pharmacokinetics and safety of BPDO-1603 or BPDO-16031 and BPDO-16033 administration in healthy adults. Randomized, open-label, single-dose, cross-over, Phase 1 study
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 or older and 55 or less at the time of screening tests
- •Men weigh 55 kg or more and women weigh 50 kg or more
- •Those with a body mass index of 18.5 kg/m2 or more and less than 27.0 kg/m2
排除标准
- •Clinically significant active chronic diseases, hepatometer (severe liver disorder, etc.), kidney (severe kidney disorder, etc.), and nervous system (hepatorespiratory tract patients). Parkinson's disease, immune system, respiratory system (asthenia, obstructive pulmonary disease, etc.), urinary system, digestive system (digestive ulcer, etc.), endocrine system, blood/tumor, cardiovascular system (cardiac infarction, heart failure, uncontrolled hypertension, atrioventricular junction disorder, etc.), or have a history.
- •A person who has a serious urinary tract infection due to renal tubular acidosis, etc. or has a history of history
- •Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
研究组 & 干预措施
BPDO-1603
Experimental
1 tablet contains memantine 20mg/donepezil 10mg
干预措施: BPDO-1603 (Drug)
BPDO-16031,BPDO-16033
Active Comparator
1 tablet memantine 20mg and 1 tablet donepezil 10mg
干预措施: BPDO-1603 (Drug)
结局指标
主要结局
Cmax of memantine and donpezil
时间窗: from baseline to day 10
pharmacokinetic properties
次要结局
- AUClast of memantine and donpezil(from baseline to day 10)
研究者
研究点 (1)
Loading locations...
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