NCT02273505已完成1 期
Comparison of Pharmacokinetics of Dipyridamole in Asasantin Extended Release (ER) 200/25 mg Capsules Bid and in a Combination of Persantin Immediate Release Tablets (100 mg Qid) and ASA Tablets (25 mg Bid) in an Open, Randomized, 2-way Crossover Study in Healthy Subjects
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
- 20
- 主要终点
- Area under the plasma concentration-time curve at steady state (AUCss)
研究概览
简要总结
Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release Persantin tablets combined with Acetyl salicylic acid (ASA) tablets
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects as determined by results of screening
- •Signed informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- •Age >= 18 and <= 55 years
- •Broca >= - 20% and <= + 20%
排除标准
- •Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
- •Surgery of the gastro-intestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •Chronic or relevant acute infections
- •History or hypersensitivity to Asasantin ER and any of the excipients
- •Intake of drugs with a long half-life (> 24 hours) (<= 1 month prior to administration or during the trial)
- •Use of any drugs which might influence the result of the trial (<= 10 days prior to administration or during the trial)
- •Participation in another trial with an investigational drug (<= 1 month prior to administration or during the trial)
- •Known alcohol abuse
- •Known drug abuse
- •Blood donation ( <=1 month prior to administration or during the trial)
- •Excessive physical activities (<=5 days prior to administration or during the trial)
- •History of hemorrhagic diseases
- •History of gastro-intestinal ulcer, perforation or bleeding
- •History of bronchial asthma
- •Any laboratory value outside the reference range of clinical relevance
- •For female subjects:
- •Pregnancy
- •Positive pregnant test
- •No adequate contraception (adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives)
- •Inability to maintain this adequate contraception during the whole study period
- •Lactation period
研究组 & 干预措施
Asasantin (ER)
Experimental
干预措施: Asasantin (ER) (Drug)
Combination of Persantin and ASA
Active Comparator
干预措施: Persantin (Drug)
Combination of Persantin and ASA
Active Comparator
干预措施: Acetyl salicylic acid (ASA) (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve at steady state (AUCss)
时间窗: Up to 144 hours after drug administration
Percentage peak trough fluctuation (%PTF)
时间窗: Up to 144 hours after drug administration
次要结局
- Time to reach maximum plasma concentration at steady state (tmax,ss) of dipyridamole(Up to 144 hours after drug administration)
- Maximum plasma concentration at steady state (Cmax,ss) of dipyridamole (dp)(Up to 144 hours after drug administration)
- Fluctuation of AUC (AUCfluct) of dipyridamole(Up to 144 hours after drug administration)
- Maximum plasma concentration at steady state / Area under the plasma concentration-time curve at steady state ((Cmax,ss) / (AUCss)) of dipyridamole(Up to 144 hours after drug administration)
- Terminal half-life in the analyte (t1/2) of dipyridamole(Up to 144 hours after drug administration)
- Urinary excretion (Ae%) of dp, dipyridamole glucuronide (dp-gluc) and salicylic acid (SA)(Up to 106 hours after drug administration)
- Number of participants with abnormal changes in clinical laboratory parameters(Up to day 7 after last drug administration)
- Number of participants with Adverse Events(Up to day 7 after last drug administration)
研究者
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