NCT03509831Unknown1 期
A Randomized, Open-label, Crossover Clinical Study to Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 After Oral Administration to Healthy Adult Male Subjects
Kukje Pharma1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年11月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral Administration to Healthy Adult Male 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.
- •Body weight >= 50 kilogram (kg) and body mass index within the range 18 - 29.0kg/m^2 (inclusive).
- •Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
排除标准
- •Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
- •History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.
- •Systolic blood pressure ≥ 150 or ≤ 100 mmHg, Diasolic blood pressure ≥ 95 or ≤ 55 mmHg.
- •Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational product.
- •Alanine aminotransferase, alkaline phosphatase <=2x upper limit of normal (ULN) total bilirubin > 2.0mg/dl and eGRF <60mL/min/1.73m2
- •History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >21 units for males. One unit is equivalent to 10 gram of alcohol.
- •The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).
研究组 & 干预措施
INT2150-A
Other
干预措施: INT-2150 (Drug)
INT2150-A
Other
干预措施: Irsogladine maleate 2 mg+Nizatidine 150 mg (Drug)
INT2150-B
Other
干预措施: INT-2150 (Drug)
INT2150-B
Other
干预措施: Irsogladine maleate 2 mg+Nizatidine 150 mg (Drug)
结局指标
主要结局
Cmax
时间窗: One day
Pharmacokinetic Characteristics
AUCt
时间窗: One day
Pharmacokinetic Characteristics
次要结局
- AUC∞(One day)
- tmax(One day)
- t1/2(One day)
研究者
研究点 (1)
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