Effects of Different Dosing and Feeding Intervals on the Pharmacokinetic Parameters of Herombopag Olamine Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This study use a single-center, randomized, open, three-cycle, self-control trial design. It is planning to enroll 15 healthy adult male subjects. Fifteen subjects will randomize into 3 test groups which corresponding to 3 different dosing sequences. Subjects will be giving a single oral dose in per cycle, and there will have three types of breakfast administration after each treatment. Washing period is 10 days during the cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years old
- •The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2
- •Signed informed consent.
排除标准
- •Any clinically serious disease that has or is currently suffering from circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic abnormalities, or any other disease that can interfere with the test results
- •Having deep vein thrombosis or other thrombotic diseases.
- •Having thrombocytopenia, mitral valve prolapse, obvious heart murmur, or murmur.
- •Extended QT interval during the screening period (calculated in Bazett's method, males >450 msec)
- •Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive.
- •Those who have a history of allergies to drugs , food or test drugs or similar drugs;
- •Those who have undergone surgery within 4 weeks prior to the trial or plan to perform surgery during the study
- •Those who took any drug within 14 days before the test (including Chinese herbal medicine)
- •Any drug that inhibits or induces liver drug metabolism within 30 days before the test
- •Subjects have participated in other clinical trial within the 3 months prior to study entry.
- •One or more non-pharmacological contraceptive measures cannot be used during the trial, or it is planned to have birth within six months.
研究组 & 干预措施
Hetrombopag Olamine A
health subjects received 7.5 mg Hetrombopag Olamine while fasting.
干预措施: Hetrombopag Olamine (Drug)
Hetrombopag Olamine B
health subjects received a high-fat meal one hour after taking7.5 mg Hetrombopag Olamine
干预措施: Hetrombopag Olamine (Drug)
Hetrombopag Olamine C
health subjects received a high-fat meal two hours after taking7.5 mg Hetrombopag Olamine
干预措施: Hetrombopag Olamine (Drug)
结局指标
主要结局
Adverse events
时间窗: from baseline up to Day 26
次要结局
- Area under the plasma concentration versus time curve (AUC)(pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group)
- Peak Plasma Concentration (Cmax)(pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group)