NCT05506007Unknown1 期
A Randomized, Open-label, Single Dose, Cross-over Clinical Trial to Compare the Safety, Tolerability, and Pharmacokinetic Properties of DA-5216 and DA-5216-R and to Evaluate the Food Effect on DA-5216 in Healthy Adult Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUClast) PK parameter
研究概览
简要总结
This is a randomized, open-label, single dose, 2-part, cross-over clinical trial to compare the safety, tolerability, and pharmacokinetic properties of DA-5216 and DA-5216-R and to evaluate the food effect on DA-5216 in healthy adult 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
- •Healthy male and female volunteer 19 years to 50 years
- •Body weight in the range of 50.0kg and body mass index in the range of 18 to 27kg/m2
- •Subject who are negative in pregnancy test or pregnant or Lactating women
- •The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
- •The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire
排除标准
- •Subject with serious active hepatobiliary, respiratory, digestive, hematologic, endocrine(diabetes mellitus, aldosteronism), immunologic, cardiovascular(hypertension, angina, heart failure, myocardial infarction, etc.), neurologic, urologic, otorhinolaryngologic, musculoskeletal, psychological disease or history of such disease
- •Subject with gastrointestinal disease (Crohn's disease, peptic ulcer, acute or chronic pancreatitis, etc.) or history of such disease/surgery (excluding simple appendic surgery, hernia surgery, hemorrhoid surgery).
- •Subject who have galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption
- •Subject who have had one or more of the following findings
- •AST, ALT > 1.5 times the upper limit
- •CPK > 2.5 times the upper limit
- •eGFR <60mL/min/1.73m2
研究组 & 干预措施
[Part A] DA-5216-R
Experimental
干预措施: DA-5216-R (Drug)
[Part B] DA-5216(Fed)
Experimental
干预措施: DA-5216 (Drug)
[Part A] DA-5216
Experimental
干预措施: DA-5216 (Drug)
[Part B] DA-5216(Fasting)
Experimental
干预措施: DA-5216 (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUClast) PK parameter
时间窗: 0~48hours
Peak Plasma Concentration (Cmax) PK parameter
时间窗: 0~48hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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