NCT02183090已完成1 期
Pharmacokinetics and Tolerability of a Single 15mg Meloxicam Dose Injected Intramuscularly Compared to a Single Oral 15 mg Meloxicam Tablet in Healthy Subjects. A Two-way Cross-over, Randomized, Open 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
- 12
- 主要终点
- tmax (Time to achieve Cmax)
研究概览
简要总结
Study to investigate the pharmacokinetics and tolerability of an intramuscular 15 mg meloxicam injection in comparison to the 15 mg oral tablet
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects as determined by results of screening
- •Written informed consent in accordance with Good Clinical Practice and local legislation
- •Age ≥ 18 and ≤ 50 years
- •Broca > - 20% and < + 20%
排除标准
- •Any findings of the medical examination (including laboratory, blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of the gastro-intestinal tract ( except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- •Chronic or relevant acute infections
- •Hypersensitivity to meloxicam and/or non-steroidal antirheumatic agents
- •Intake of drugs with a long half-life (>24 hours) (≤ 1 month prior to administration or during the trial)
- •Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
- •Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
- •Smoker (>= 10 cigarettes or >= 3 cigars or >= 3 pipes/day)
- •Inability to refrain from smoking on study days
- •Known alcohol abuse
- •Known drug abuse
- •Blood donation (≤ 1 month prior to administration)
- •Excessive physical activities (≤ 5 days prior to administration)
- •History of hemorrhagic diatheses
- •History of gastro-intestinal ulcer, perforation or bleeding
- •History of bronchial asthma
- •For female subjects:
- •Pregnancy
- •Positive pregnancy test
- •No adequate contraception e.g. sterilization, IUD (intrauterine device), oral contraceptives
- •Inability to maintain this adequate contraception during the whole study period
- •Lactation period
研究组 & 干预措施
Meloxicam ampoule
Experimental
干预措施: Meloxicam ampoule (Drug)
Meloxicam tablet
Active Comparator
干预措施: Meloxicam tablet (Drug)
结局指标
主要结局
tmax (Time to achieve Cmax)
时间窗: up to 96 hours after drug administration
AUC0-inf (total area under the plasma drug concentration-time curve)
时间窗: up to 96 hours after drug administration
Cmax (Maximum drug plasma concentration)
时间窗: up to 96 hours after drug administration
次要结局
- Change from baseline in laboratory parameters(Baseline, days 1-2 and 5 of each treatment period)
- t1/2 (apparent terminal elimination half-life)(up to 96 hours after drug administration)
- λz (apparent terminal elimination rate constant)(up to 96 hours after drug administration)
- Vz/f (Apparent volume of distribution during the terminal phase λz following extravascular administration)(up to 96 hours after drug administration)
- Change from baseline in vital signs (pulse rate, systolic and diastolic blood pressure)(Baseline, days 1-5 of each treatment period)
- Number of patients with adverse events(up to 72 hours after day 5 of each treatment period)
- Tolerability of the intramuscular injection(before and 4 and 24 hours after application of study drug)
- AUC0-t (Total area under the plasma drug concentration-time curve from time of administration to the time of the last quantifiable drug concentration)(up to 96 hours after drug administration)
- MRTtot (Mean residence time)(up to 96 hours after drug administration)
- CL/f (Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration)(up to 96 hours after drug administration)
研究者
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