NCT02254226已完成1 期
A Randomised, Open-label Four-way Crossover Study to Evaluate Pharmacokinetics of Salmeterol (Serevent®) After Inhalation of a 25 μg and 50 μg Single Dose (Metered Dose Inhaler) and a 50 μg and 100 μg Single Dose (Diskus®) 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
- 26
- 主要终点
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
研究概览
简要总结
- To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg Serevent ® MDI with sufficient precision so that in combination with a second trial it can be demonstrated that the systemic drug exposure of a new formulation of salmeterol xinafoate is not superior to that of Serevent ® MDI
- To test a system of ordered null hypotheses regarding the exposure of two dose levels of Serevent ® Diskus ® and Serevent ® MDI
- To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg Serevent ® Diskus ®
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
- •Healthy males according to the following criteria:
- •Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram) , clinical laboratory tests 1.1 No finding deviating from normal and of clinical relevance 1.2 No evidence of a clinically relevant concomitant disease
- •Age ≥21 and ≤50 years
- •BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
排除标准
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of relevant 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 1 month or less than 10 half-lives of the respective drug prior to administration or during the trial.
- •Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial.
- •Participation in another trial with an investigational drug within 2 months prior to administration or during the trial.
- •Smoker (more than 10 cigarettes or three cigars or three pipes per day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (more than 60 g/day)
- •Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
- •Excessive physical activities (within 1 week prior to administration or during the trial)
- •Any laboratory value outside the reference range that is of clinical relevance
- •Inability to comply with dietary regimen of study centre
- •Exclusion criterion specific for this study:
- •Asthma or history of pulmonary hyperreactivity
- •Allergy / hypersensitivity to Lactose monohydrate
- •Hyperthyrosis
- •Allergic rhinitis in need of treatment
- •Cardiac arrhythmia
- •Paroxysmal tachycardia (> 100 beats per minute)
- •Aortic stenosis
研究组 & 干预措施
Salmeterol Diskus high
Experimental
干预措施: Salmeterol Diskus high (Drug)
Salmeterol Diskus low
Experimental
干预措施: Salmeterol Diskus low (Drug)
Salmeterol MDI low
Experimental
干预措施: Salmeterol MDI low (Drug)
Salmeterol MDI high
Active Comparator
干预措施: Salmeterol MDI high (Drug)
结局指标
主要结局
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
时间窗: Up to 6 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: Up to 6 hours after drug administration
次要结局
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(Up to 6 hours after drug administration)
- AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)(Up to 6 hours after inhalation)
- tmax (time from dosing to the maximum concentration of the analyte in plasma)(Up to 6 hours after drug administration)
- λz (terminal rate constant in plasma)(Up to 6 hours after drug administration)
- t½ (terminal half-life of the analyte in plasma)(Up to 6 hours after drug administration)
- MRTinh (mean residence time of the analyte in the body after inhalational administration)(Up to 6 hours after drug administration)
- Number of participants with clinically significant changes in vital signs(Up to 15 days after last drug administration)
- Number of participants with abnormal findings in ECG(Up to 15 days after last drug administration)
- Number of participants with abnormal changes in clinical laboratory parameters(Up to 15 days after last drug administration)
- Number of participants with adverse events(Up to 15 days after last drug administration)
- CL/F (apparent clearance of the analyte in the plasma after extravascular administration)(Up to 6 hours after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(Up to 6 hours after drug administration)
- Aet1-t2 (amount of analyte that was eliminated in urine from the time interval t1 to t2)(Up to 6 hours after inhalation)
- fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)(Up to 6 hours after inhalation)
- CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)(Up to 6 hours after inhalation)
- Number of participants with abnormal findings in physical examination(Up to 15 days after last drug administration)
研究者
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