NCT02194270已完成1 期
Relative Bioavailability of Ambroxol Hydrochloride Following Oral Administration of Soft Pastilles 15 mg (Test) Compared to 15 mg of Syrup (15mg/5mL, Reference I) and Compared to 15 mg of Syrup (30mg/5mL) (Reference II) in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, 3-way Crossover Study
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
- 24
- 主要终点
- Cmax (maximum concentration of the analyte in plasma)
研究概览
简要总结
Study to investigate the relative bioavailability of ambroxol hydrochloride soft pastilles 15 mg vs. ambroxol hydrochloride (HCL) 15 mg of syrup (15mg/5mL, Reference I) and ambroxol hydrochloride 15 mg of syrup (30mg/5mL, Reference II) in a fasted 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 males and females 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 Electrocardiogram (ECG), clinical laboratory tests
- •No finding deviating from normal and of clinical relevance
- •No evidence of a clinically relevant concomitant disease
- •Age ≥18 and Age ≤55 years
- •BMI ≥18.5 and BMI ≤29.9 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
- •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 one 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 two months prior to administration or during the trial
- •Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- •Alcohol abuse (more than 60 g/day)
- •Drug abuse
- •Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- •Excessive physical activities (within one 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
- •For female subjects:
- •Pregnancy
- •Positive pregnancy test
- •No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
- •Inability to maintain this adequate contraception during the whole study period
- •Lactation period
研究组 & 干预措施
Ambroxol hydrochloride - soft pastille
Experimental
干预措施: Ambroxol hydrochloride - soft pastille (Drug)
Ambroxol hydrochloride - syrup - low dose
Active Comparator
干预措施: Ambroxol hydrochloride - syrup - low dose (Drug)
Ambroxol hydrochloride - syrup - high dose
Active Comparator
干预措施: Ambroxol hydrochloride - syrup - high dose (Drug)
结局指标
主要结局
Cmax (maximum concentration of the analyte in plasma)
时间窗: up to 30 hours after each drug administration
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 30 hours after each drug administration
次要结局
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(up to 30 hours after each drug administration)
- 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 30 hours after each drug administration)
- λz (terminal rate constant in plasma)(up to 30 hours after each drug administration)
- Assessment of tolerability by investigator on a 4-point scale(within 8 days after last administration)
- tmax (time from dosing to the maximum concentration of the analyte in plasma)(up to 30 hours after each drug administration)
- MRTpo (mean residence time of the analyte in the body after p.o. (oral) administration)(up to 30 hours after each drug administration)
- Number of patients with clinically significant changes in vital signs (BP (Blood pressure), PR (Pulse rate))(up to 40 days)
- t1/2 (terminal half-life of the analyte in plasma)(up to 30 hours after each drug administration)
- CL/F (apparent clearance of the analyte in the plasma after extravascular administration)(up to 30 hours after each drug administration)
- Number of patients with adverse events(up to 40 days)
- Number of patients with abnormal changes in laboratory parameters(up to 40 days)
研究者
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