NCT02264106已完成1 期
Influence of 40 mg Pantoprazole Per Day on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of 30 mg Lefradafiban Tid as Acid Free Tablet and Sachet Over 5 Days in Healthy Subjects. A 4-way Crossover Randomized Open Trial
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
- 12
- 主要终点
- Area under the concentration-time curve of the analyte in plasma at steady state, 13th dosing interval (AUCss,13)
研究概览
简要总结
To assess the absorption of 30 mg Lefradafiban in two formulations, each under physiological conditions and with 40 mg Pantoprazole
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects as determined by results of screening
- •Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- •Age ≥ 18 and ≤ 60 years, planned stratification: age < 40 years (4 subjects) and ≥ 40 years (8 subjects)
- •Broca ≥ - 20 % and ≤ + 20 %
排除标准
- •Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
- •Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- •Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- •Drug abuse
- •Alcohol abuse (> 60 g/day)
- •Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- •Excessive physical activities within 5 days prior to administration or during the trial
- •Blood donation within 1 month prior to administration or during the trial
- •History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders
- •Chronic or relevant acute infections
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- •History of
- •Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Any bleeding disorder including prolonged or habitual bleeding
- •Other hematologic disease
- •Cerebral bleeding (e.g. after a car accident
- •Recent surgical procedures
- •Thrombocytes < 150000/µ
- •Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Any laboratory value outside the clinically accepted reference range
- •Other disease or abnormality of clinical relevance
研究组 & 干预措施
Lefradafiban tablet with pantoprazole
Experimental
干预措施: Lefradafiban tablet (Drug)
Lefradafiban tablet with pantoprazole
Experimental
干预措施: Pantoprazole (Drug)
Lefradafiban tablet
Active Comparator
干预措施: Lefradafiban tablet (Drug)
Lefradafiban double chamber sachet with pantoprazole
Experimental
干预措施: Lefradafiban double chamber sachet (Drug)
Lefradafiban double chamber sachet with pantoprazole
Experimental
干预措施: Pantoprazole (Drug)
Lefradafiban double chamber sachet
Active Comparator
干预措施: Lefradafiban double chamber sachet (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma at steady state, 13th dosing interval (AUCss,13)
时间窗: Up to 168 hours after first drug administration
Amount of the analyte eliminated unchanged in the urine per dosing interval i expressed as percent of applied dose and corrected for molecular weight differences (Ae% (i=1,...,13))
时间窗: Up to 168 hours after first drug administration
Maximum concentration of the analyte in plasma at steady state, 13th dosing interval (Cmax,ss,13)
时间窗: Up to 168 hours after first drug administration
Pre-dose concentration of the analyte in plasma at steady state, 13th dosing interval (Cpre,ss,13)
时间窗: Up to 168 hours after first drug administration
次要结局
- Pre-dose concentration of the analyte in plasma for the i-th dosing interval (Cpre,i (i=1,4,7,10,11,12))(Up to 90 hours after first drug administration)
- Plasma concentration of the analyte at 2 hours post-dose for the i-th dosing interval (C2h,i (i=10,11,12))(Up to 98 hours after first drug administration)
- Percent swing of peak/trough concentrations of the analyte in plasma for the i-th dosing interval (%Swingi)(Up to 168 hours after first drug administration)
- Terminal half life of the analyte in plasma (t1/2)(Up to 168 hours after first drug administration)
- Percent peak-trough fluctuation for the 13th dosing interval (%PTF13)(Up to 168 hours after first drug administration)
- Number of patients with clinically relevant findings in laboratory tests(up to 168 hours after first drug administration)
- Fibrinogen receptor occupancy levels(Up to 168 hours after first drug administration)
- Number of patients with clinically relevant findings in vital signs(up to day 8 after first drug administration)
- Number of patients with adverse events(Up to 3 days after last drug administration)
- Percent fluctuation of area under the plasma concentration-time curve (AUCfluc,13)(Up to 168 hours after first drug administration)
研究者
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