NCT02183103已完成1 期
Influence of a High Fat Breakfast in the Pharmacokinetics of UH-AC62MU (Rapid Release Tablet) Given as an Oral Single Dose of 7.5 mg in Healthy Subjects (Two Way, Crossover, Randomized, Open)
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
- 8
- 主要终点
- Maximum measured concentration of the analyte in plasma (Cmax)
研究概览
简要总结
Influence of a high fat breakfast in the pharmacokinetic profile of the 7.5 mg meloxicam rapid releases 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 according 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 (blood pressure, pulse rate and electrocardiogram (ECG)) deviating from the normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
- •Surgery of gastro-intestinal tract (except appendectomy)
- •Disease of central nervous system (such as epilepsy) or psychiatric disorders or neurological disorder
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life ( >24h) (<=1month prior to administration)
- •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)
- •Smokers ( >10 cigarettes or >3 cigars or >3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (>60g/day)
- •Drug abuse
- •Blood donation (<= 1 month prior to administration or during the trial)
- •Excessive physical activities (<= 5 days prior to administration or during the trial)
- •Any laboratory value outside the reference range of clinical relevance
- •History of hemorrhagic diatheses
- •History of gastro-intestinal ulcer, perforation or bleeding
- •History of bronchial asthma
- •For female:
- •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
- •Lactation period
研究组 & 干预措施
meloxicam rapid release tablet after an overnight fast
Active Comparator
干预措施: meloxicam rapid release tablet, 12mg, UH AC62MU (Drug)
meloxicam rapid release tablet after high fat breakfast
Experimental
干预措施: meloxicam rapid release tablet, 12mg, UH AC62MU (Drug)
结局指标
主要结局
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: predose and up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity)
时间窗: predose and up to 96 hours after drug administration
次要结局
- Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t)(predose and up to 96 hours after drug administration)
- Terminal rate constant in plasma (λz)(predose and up to 96 hours after drug administration)
- Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)(predose and up to 96 hours after drug administration)
- Number of patients with abnormal changes in laboratory values(Baseline, 96 hours after drug administration)
- Mean residence time of the analyte total (MRT tot)(predose and up to 96 hours after drug administration)
- Number of Participants with Adverse Events(Up to day 5 after last drug administration)
- Number of patients with abnormal changes from baseline in physical examination(Baseline, day 5 after last drug administration)
- Time to achieve Cmax (tmax)(predose and up to 96 hours after drug administration)
- Apparent clearance of the analyte in plasma following extravascular administration (CL/F)(predose and up to 96 hours after drug administration)
- Terminal half-life of the analyte in plasma (t1/2)(predose and up to 96 hours after drug administration)
- Number of patients with abnormal changes from baseline in ECG(Baseline, day 5 after last drug administration)
研究者
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