NCT02180490已完成1 期
Bioequivalence Study of UHAC 62 XX 10 mg Tablets Compared With 10 mg Capsules Following Single 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
- 60
- 主要终点
- Cmax (Maximum observed concentration of the analyte in plasma)
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) in fasted state.
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: BMI >= 18.5 and < 25 (Weight (kg) / Height (m²)
- •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) 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 administration
- •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 tablet
Experimental
干预措施: UHAC 62 XX capsule (Drug)
UHAC 62 XX capsule
Active Comparator
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
Cmax (Maximum observed concentration of the analyte in plasma)
时间窗: up to 60 hours after drug administration
AUC 0-60hr (Area under the concentration time curve of the analyte in plasma from zero time to 60 hours)
时间窗: up to 60 hours after drug administration
次要结局
- MRT 0-infinity (Mean residence time of the analyte molecules in the body from zero time to infinity)(up to 60 hours after drug administration)
- Number of patients with adverse events(up to 20 days after final drug administration)
- Tmax (Time to reach Cmax)(up to 60 hours after drug administration)
- t1/2 ( Terminal half-life of the analyte in plasma)(up to 60 hours after drug administration)
- AUC 0-infinity (Area under the concentration time curve of the analyte in plasma from zero time to infinity)(up to 60 hours after drug administration)
研究者
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