Clinical Trial for the Safety, Tolerability, and Pharmacokinetics of TEW-7197 Under Fed or Fasting in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetics:Maximum Concentration (Cmax)
研究概览
简要总结
Participants in this study will receive 200 milligram (mg) TEW-7197 taken at 7days apart. One dose will be given under fasting . The Other dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 2weeks not including screening.
详细描述
Through screening (D-30 ~ D-1) prior to the first dose of the investigational product, a total of 16 subjects (Group 1: 8 subjects, Group 2: 8 subjects) who were eligible for the inclusion criteria and exclusion criteria were enrolled. This clinical study has a randomized, open, single dose, 2-sequence, 2-period cross-over design and TEW-7197 50 mg x 4 tablets were administered as a single dose in the same individual for 2 periods after fasting or a high fat diet, and each period was repeated with an interval of at least 1 week of wash-out. Pharmacokinetics and safety were evaluated in all subjects according to the planned schedule
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Healthy sterile males
- •BMI 18.0kg/m2 - 27.0 kg/m2
- •No congenital or chronic disease and no pathological symptoms or pathological findings
- •Investigator confirm that the subject is eligible through a medical examination (medical history taking ,vital signs, ECG, cardiac ultrasonography, blood science)
排除标准
- •Has pathological symptoms or pathological findings
- •Has a history of disease that may affect the absorption, distribution, metabolism and excretion of a drug
- •SBP>140 or <90 mmhg , DBP>90 or <60mmHg ,Pulse>100
- •No abnormal Clinical Lab findings
研究组 & 干预措施
Group I (Fasted->Fed)
Group 1 received a single oral dose in a fasting condition in Period 1, followed by a single oral dose after a high-fat diet in Period 2
干预措施: TEW-7197 (Drug)
Group II(Fed->Fasted)
Group 2 received a single oral dose after a high-fat diet in Period 1, followed by a single oral in a fasting condition in Period 2
干预措施: TEW-7197 (Drug)
结局指标
主要结局
Pharmacokinetics:Maximum Concentration (Cmax)
时间窗: Pre-dose through 24 hours post-dose in each period of the. study
Maximum Concentration (Cmax)
Pharmacokinetics:Area Under the Concentration Curve (AUC)
时间窗: Pre-dose through 24 hours post-dose in each period of the. study
Area Under the Concentration Curve (AUC) of TEW-7197
次要结局
未报告次要终点