NCT02259998已完成1 期
An Open-labelled, Randomised, 2-way Crossover Study to Compare the Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets 75 mg p.o. (Present and Proposed Formulation in France) q.i.d. for Three Days in Healthy Male 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
- 30
- 主要终点
- Area under the concentration time curve from 48 to 58 hours (AUC48-58)
研究概览
简要总结
To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation.
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
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All participants in the study should be healthy males, range from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2
- •All participants must give their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study
排除标准
- •Any finding 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
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug before enrolment in the study or during the study
- •Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- •Participation in another trial with an investigational drug (<= two months prior to administration or during the trial)
- •Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation (>= 100 ml within four weeks prior to administration or during the trial)
- •Any laboratory value outside the clinically accepted reference range
- •Excessive physical activities within the last week before the trial or during the trial
- •Following exclusion criteria are of special interest for this study:
- •History of haemorrhagic diathesis
- •History of gastro-intestinal ulcer, perforation or bleeding
- •Glucose-6-phosphate-dehydrogenase (G-6-PD) deficiency
研究组 & 干预措施
Persantin® new formulation
Experimental
干预措施: Persantin® new formulation (Drug)
Persantin® commercial formulation
Active Comparator
干预措施: Persantin® commercial formulation (Drug)
结局指标
主要结局
Area under the concentration time curve from 48 to 58 hours (AUC48-58)
时间窗: 48 - 58 hours
Maximum concentration from 48 to 58 hours (Cmax48-58)
时间窗: 48 - 58 hours
次要结局
- Peak trough fluctuation (% PTF)(up to 48 hours)
- Minimum concentration from 48 to 58 hours (Cmin48-58)(48 - 58 hours)
- Cmax48-58/AUC48-58 ratio(48 - 58 hours)
- Time to maximum concentration from 48 to 58 hours (Tmax48-58)(up to 58 hours)
- Amount excreted in urine (Ae)(up to 24 hours after drug administration)
- Number of participants with adverse events(up to 8 days after last drug administration)
- Number of participants with clinically significant findings in vital functions(up to 8 days after last drug administration)
- Number of participants with clinically significant findings in ECG(up to 8 days after last drug administration)
- Number of participants with clinically significant findings in laboratory tests(up to 8 days after last drug administration)
研究者
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