NCT02273492已完成1 期
Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin Extended Release (ER) 200/25 mg Capsules b.i.d. in a Randomized, Open, 2-way Cross-over 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
- 28
- 主要终点
- Maximum concentration of dipyridamole in plasma from 0 to 10h (Cmax,0-10h)
研究概览
简要总结
Comparative pharmacokinetics and pharmacodynamics of Asasantin ER at fasted and fed state
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 written 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 disorders
- •Surgery of the gastro-intestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- •Chronic or relevant acute infections
- •History of 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 results 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)
- •Excessive physical activities (< 5 days prior to administration)
- •History of hemorrhagic diatheses
- •History of gastro-intestinal ulcer, perforating or bleeding
- •History of bronchial asthma
- •Any laboratory value outside the normal range of clinical relevance
- •Female subjects:
- •Pregnancy
- •Positive pregnancy test
- •No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (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 after a standardized breakfast
Experimental
干预措施: Asasantin ER (Drug)
Asasantin ER after a standardized breakfast
Experimental
干预措施: Standardized breakfast (Other)
Asasantin ER at fasted state
Active Comparator
干预措施: Asasantin ER (Drug)
结局指标
主要结局
Maximum concentration of dipyridamole in plasma from 0 to 10h (Cmax,0-10h)
时间窗: up to 10 hours after drug administration
Area under the concentration-time curve of dipyridamole in plasma at steady state (AUCss)
时间窗: Up to 144 hours
Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte thromboxane B2 (TXB2)
时间窗: up to day 19
Maximum concentration of dipyridamole in plasma at steady state (Cmax,ss)
时间窗: Up to 144 hours
次要结局
- Time to reach the maximum concentration of the analytes in plasma at steady state (Tmax,ss)(Up to 144 hours)
- Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)(Up to 144 hours)
- Percent peak trough fluctuation of dipyridamole in plasma (%PTF)(Up to 144 hours)
- Terminal half-life of the analytes in plasma (t1/2)(Up to 144 hours)
- Percent area under the curve fluctuation of dipyridamole in plasma (AUCfluct)(Up to 144 hours)
- Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte malondialdehyde(up to day 19)
- Area under the concentration-time curve of the analyte in plasma from 0 to 10 h (AUC0-10h)(Up to 10 hours after start of drug administration)
- Area under the concentration-time curve of ASA in plasma at steady state (AUCss)(Up to 144 hours)
- Maximum concentration of ASA in plasma at steady state (Cmax,ss)(Up to 144 hours)
- Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)(up to day 7)
- Number of subjects with abnormal changes in laboratory parameters(Up to 144 hours)
- Number of subjects with adverse events(up to 2 months)
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