NCT02183077已完成1 期
Pharmacokinetics and Tolerability of 2 x 15 mg Meloxicam (2 x 0.3 g Topical Gel) Over 7 Days Compared to 7.5 mg Meloxicam Tablet (Single Oral Dose) 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
- Analysis of plasma concentration-time course after topical dose
研究概览
简要总结
Study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days.
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
- •Signed 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 blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of the gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- •Chronic or relevant acute infections
- •Hypersensitivity to meloxicam and any of the excipients 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 months prior to administration)
- •Excessive physical activities (<= 5 days prior to administration)
- •History of hemorrhagic diatheses
- •History of gastrointestinal ulcer, perforation or bleeding
- •History of bronchial asthma
- •Any laboratory value outside the normal range of clinical relevance
- •History of dermatological diseases
- •Skin disease and/or skin lesions at the site of planned application
- •For female subjects:
- •Pregnancy
- •Positive pregnancy test
- •Breast feeding
研究组 & 干预措施
Meloxicam gel
Experimental
干预措施: Meloxicam gel (Drug)
Meloxicam tablet
Active Comparator
干预措施: Meloxicam tablet (Drug)
结局指标
主要结局
Analysis of plasma concentration-time course after topical dose
时间窗: up to 264 hours after first topical administration
Determination of the ratio AUCss topical/AUC0-∞ oral
时间窗: up to 96 hours after oral administration
次要结局
- Apparent terminal elimination rate constant(up to 264 hours after first topical administration)
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(up to 96 hours after oral administration)
- Mean residence time (MRTtot)(up to 96 hours after oral administration)
- Time from dosing to the maximum concentration of the analyte in plasma (Tmax)(up to 96 hours after oral administration)
- Excretion of metabolites in urine(0-24 hours after oral administration)
- Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)(up to 264 hours after first topical administration)
- Total area under the plasma drug concentration time curve (AUC) during a steady state interval (AUCss)(up to 264 hours after first topical administration)
- Maximum measured concentration of the analyte in plasma (Cmax)(up to 96 hours after oral administration)
- 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)(up to 96 hours after oral administration)
- Apparent clearance of the analyte in plasma following extravascular administration (CL/F)(up to 96 hours after oral administration)
- Terminal half-life of the analyte in plasma (t½)(up to 264 hours after first topical administration)
- Apparent volume of distribution of the analyte during the terminal phase (Vz/F)(up to 96 hours after oral administration)
- Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)(up to 264 hours after first topical administration)
- Occurence of adverse events(up to 24 days)
- Assessment of local and systemic tolerability(up to 24 days)
- Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)(up to 264 hours after first topical administration)
研究者
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