NCT02187575已完成1 期
Bioequivalence Study of UHAC62XX 10 mg Tablets Compared With 10 mg Capsules Following Multiple Peroral Administration in Healthy Volunteers (An Open-label, Randomised, Two-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
- 26
- 主要终点
- AUC 0-τ (Area under the concentration time curve in plasma from zero time to 24 hours after 7-day administration)
研究概览
简要总结
Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.
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
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age >= 20 and <= 35 years
- •Weight: Body Mass Index >= 18.5 and < 25
- •Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test
- •Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent
排除标准
- •History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
- •History of hypersensitivity to UHAC 62 XX and/or salicylate (aspirin etc.) and/or Non-steroidal anti-inflammatory drugs (NSAIDs)
- •History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
- •History of bleeding tendency
- •History of alcohol or drug abuse
- •Participation to another trial with an investigational drug within 4 months prior to the trial
- •Whole blood donation more than 400 ml within 3 months prior to the trial
- •Whole blood donation more than 100 ml within 1 month prior to the trial
- •Donation of constituent of blood of more than 400 ml within 1 month prior to the trial
- •Any medication which might influence the results of the trial within 10 days prior to the trial
- •Excessive physical activities within 7 days prior to the trial
- •Alcohol drinking within 3 days prior to the trial
- •History of orthostatic hypotension, fainting spells or blackouts
- •Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study
研究组 & 干预措施
UHAC 62 XX tablet
Experimental
干预措施: UHAC 62 XX tablet (Drug)
UHAC 62 XX capsule
Active Comparator
干预措施: UHAC 62 XX capsule (Drug)
结局指标
主要结局
AUC 0-τ (Area under the concentration time curve in plasma from zero time to 24 hours after 7-day administration)
时间窗: up to day 8
Cmax (maximum observed concentration of the analyte in plasma)
时间窗: up to day 8
次要结局
- Tmax (Time to reach Cmax)(up to day 8)
- Number of patients with adverse events(up to 20 days after final administration)
- T1/2 (Terminal half-life in plasma)(up to day 8)
- MRT 0-τ (Mean residence time in the body after 7-day administration)(up to day 8)
- Cτ (Concentration of the analyte in plasma 24 hours after 7-day administration)(up to day 8)
研究者
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