NCT02254187已完成1 期
A Randomised, Open-label Three-way Crossover Study to Evaluate the Pharmacokinetics of Salmeterol After Inhalation of a 25 μg and 50 μg Single Dose (Inhalation Powder, Hard PE Capsule for HandiHaler®2) and a 50 μg Single Dose (Serevent® 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
- 30
- 主要终点
- AUC0-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity)
研究概览
简要总结
The objective of this study is to investigate if the systemic drug exposure of at least 25 μg and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to investigate safety and tolerability of salmeterol presented as inhalation powder in PE capsules and administered via HandiHaler® 2
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 male based upon a complete medical history, including the physical examination, regarding vital signs ((Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is 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
- •Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- •Evidence of a clinically relevant concomitant disease
- •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 relevant orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant 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 randomization
- •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 randomization
- •Participation in another trial with an investigational drug within 2 months prior to randomization
- •Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- •Inability to refrain from smoking on trial days as judged by the investigator
- •Alcohol abuse (more than 60 g alcohol a day)
- •Blood donation (more than 100 mL blood within 4 weeks prior to randomization or during the trial)
- •Excessive physical activities within 1 week prior to randomization or during the trial
- •Any laboratory value outside the reference range that is of clinical relevance
- •Inability to comply with dietary regimen of the study centre
- •The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:
- •Asthma or history of pulmonary hyperreactivity
- •Hyperthyrosis
- •Allergic rhinitis in need of treatment
- •Clinically relevant cardiac arrhythmia
- •Paroxysmal tachycardia (>100 beats per minute)
研究组 & 干预措施
Salmeterol capsule via Handihaler - low
Experimental
干预措施: Salmeterol capsule - low (Drug)
Salmeterol capsule via Handihaler - high
Experimental
干预措施: Salmeterol capsule - high (Drug)
Salmeterol via Serevent® Diskus®
Active Comparator
干预措施: Salmeterol via Serevent® Diskus® (Drug)
结局指标
主要结局
AUC0-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity)
时间窗: up to 8 hours after drug administration
Cmax (maximum measured concentration of salmeterol in blood plasma)
时间窗: up to 8 hours after drug administration
次要结局
- Number of patients with abnormal changes in laboratory parameters(up to 14 days following the last drug administration)
- Number of patients with clinically significant changes in vital signs(up to 14 days following the last drug administration)
- Assessment of tolerability by investigator on a 4-point scale(14 days following the last drug administration)
- AUC0-tz (area under the concentration-time curve of salmeterol in plasma over the time interval from 0 to the time of the last quantifiable data point)(up to 8 hours after drug administration)
- Number of patients with clinically significant changes in 12-lead ECG parameters(up to 14 days following the last drug administration)
- Number of patients with adverse events(up to 14 days following the last drug administration)
- t½ (terminal half-life of salmeterol in plasma)(up to 8 hours after drug administration)
- AUCt1-t2 (area under the concentration time curve of salmeterol in plasma over the time interval t1 to t2)(up to 8 hours after drug administration)
- tmax (time from dosing to the maximum concentration of salmeterol in plasma)(up to 8 hours after drug administration)
- MRTih (mean residence time of salmeterol in the body after inhalational administration)(up to 8 hours after drug administration)
- λz (terminal rate constant in plasma)(up to 8 hours after drug administration)
- CL/F (apparent clearance of salmeterol in the plasma after extravascular administration)(up to 8 hours after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose)(up to 8 hours after drug administration)
研究者
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