NCT02276352已完成1 期
An Open, Randomized, Three-way Cross-over Study in Healthy Volunteers to Evaluate the Relative Bioavailability of Meloxicam After Single p.o. Administration of 2 x 7.5 mg Meloxicam Tablets Compared to 15 mg Meloxicam Tablet, and Dose-proportionality Over a Dosage Range of 7.5 mg and 15 mg.
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
- 18
- 主要终点
- Maximum measured concentration of the analyte in plasma (Cmax)
研究概览
简要总结
Study to assess the relative bioavailability of two 7.5 mg meloxicam tablets (American type) compared to one 15 mg meloxicam tablet (American type), and to investigate dose-proportionality over the dosage range 7.5 mg to 15 mg
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 (GCP) and local legislation
- •Age >= 18 and <= 50 years
- •Broca >= -20% and <= + 20 %
排除标准
- •Any finding of the medical examination (including laboratory blood pressure, pulse rate and 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
- •Alcohol abuse
- •Drug abuse
- •Blood donation (<= 1 months 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, intrauterine device (IUD), oral contraceptives
- •Inability to maintain this adequate contraception during the whole study period
- •Lactating
研究组 & 干预措施
Meloxicam low dose - one tablet
Experimental
干预措施: Treatment 1 (Drug)
Meloxicam high dose - two tablets
Experimental
干预措施: Treatment 2 (Drug)
Meloxicam high dose - one tablet
Active Comparator
干预措施: Treatment 3 (Drug)
结局指标
主要结局
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
时间窗: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose
次要结局
- Apparent terminal elimination rate constant (λz )(predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose)
- Terminal half-life of the analyte in plasma (t½)(predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose)
- Mean residence time (MRTtot)(predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose)
- Time from dosing to the maximum concentration of the analyte in plasma (tmax)(predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose)
- Total area under the plasma drug concentration time curve (AUC) from time of administration to the time of the last quantifiable drug concentration (AUC0-t)(predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose)
- Apparent clearance of the analyte in plasma following extravascular administration (CL/F)(predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose)
- Apparent volume of distribution of the analyte during the terminal phase (Vz/F)(predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose)
- Number of patients with abnormal findings in pulse rate(predose, up to 96:00 h post dose)
- Number of patients with abnormal findings in systolic and diastolic blood pressure(predose, up to 96:00 h post dose)
- Number of patients with adverse events(up to 39 days)
- Number of patients with abnormal changes in laboratory parameters(predose, up to 96:00 h post dose)
研究者
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