NCT02268773已完成1 期
A Randomised, Two-period, Cross-over Trial to Compare the Effects of Acetylsalicylic Acid (75 mg/Day) With the Combination of Acetylsalicylic Acid (25 mg) + Modified-release Dipyridamole (200 mg) (bd) on Serum Thromboxane B2 Formation and Platelet Aggregation in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Absolute serum thromboxane B2 level
研究概览
简要总结
To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect on inhibition of thromboxane B2 formation
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy volunteers aged 20 to 50 years
- •Clinically normal medical history
- •Clinically normal findings on physical examination
- •Capable of comprehending and communicating effectively with the investigator and staff and of providing informed consent
- •Willing to give informed consent prior to participation in the trial (i.e. prior to any trial-specific procedures)
排除标准
- •Any clinically significant disease. (A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study or a disease which may influence the results of the study or the subject's ability to participate in the study)
- •Clinically significant abnormal baseline haematology, blood chemistry or urinalysis findings
- •Serum glutamate-oxaloacetate transferase (SGOT) or serum glutamate-pyruvate transferase (SGPT) > 80 IU/L, bilirubin > 34 µmol/L or creatinine > 176 µmol/L regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these subjects
- •Use of dipyridamole, aspirin or any non-steroidal anti-inflammatory agent (NSAID) during the previous two weeks
- •Active peptic ulceration or history of peptic ulcer disease
- •Known history of or suspected hypersensitivity to dipyridamole, aspirin, any NSAID or any other component of the test drugs
- •History of any bleeding disorders
- •History of cerebral haemorrhage
- •Resting, seated blood pressure less than 90/60 mmHg
- •Participation in any drug clinical trial within sixteen weeks prior to the start of the trial
- •Any indication of current or previous abuse of alcohol, solvents or drugs
- •Any chronic illness
- •Requirement for any other medication one month before or during the study
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices or surgically sterile) were to be excluded
- •Previous participation in the randomisation phase of this clinical trial
研究组 & 干预措施
Acetylsalicylic acid low dose with Asasantin®
Experimental
干预措施: Asasantin® (Drug)
Acetylsalicylic acid low dose with Asasantin®
Experimental
干预措施: Acetylsalicylic acid low dose (Drug)
Acetylsalicylic acid high dose
Active Comparator
干预措施: Acetylsalicylic acid high dose (Drug)
结局指标
主要结局
Absolute serum thromboxane B2 level
时间窗: At day 3 after start of drug administration
次要结局
- Changes from baseline in physical examination(Pre-dose, up to 14 days after first drug administration)
- Change in platelet aggregation(At day 3 after start of drug administration)
- Change in time course of inhibition of platelet aggregation(Pre-dose, up to day 14 after start of drug administration)
- Number of patients with adverse events(Up to 14 days after start of drug administration)
- Change in time course of inhibition of serum thromboxane B2(Pre-dose, up to day 14 after start of drug administration)
- Changes from baseline in vital signs(Pre-dose, up to 14 days after first drug administration)
- Changes from baseline in laboratory tests(Pre-dose, up to 14 days after first drug administration)
- Changes from baseline in 12-lead ECG(Pre-dose, up to 14 days after first drug administration)
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