NCT02181907已完成1 期
Bioequivalence Study of UH-AC 62 XX Tablets 10 mg (TF4) Compared With the 10 mg Capsule Formulations Following Single Peroral Administration in Healthy Volunteers
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
- 22
- 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 of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX capsules 10 mg by single administration in healthy volunteers.
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 to 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 UH-AC 62 XX (meloxicam) or salicylate (aspirin etc.) or Non-steroidal anti-inflammatory drugs (NSAIDs)
- •History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
- •A tendency of bleeding
- •History of alcohol or drug abuse
- •Taking 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 could 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 were judged by the investigator to be inappropriate as the subjects of the study
研究组 & 干预措施
UH-AC 62 XX tablet
Experimental
干预措施: UH-AC 62 XX tablet (Drug)
UH-AC 62 XX tablet
Experimental
干预措施: UH-AC 62 XX capsule (Drug)
UH-AC 62 XX capsule
Active Comparator
干预措施: UH-AC 62 XX tablet (Drug)
UH-AC 62 XX capsule
Active Comparator
干预措施: UH-AC 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
- Tmax (Time to reach Cmax)(up to 60 hours after drug administration)
- MRTpo (Mean residence time of the analyte in the body after single dose po administration)(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)
- t1/2 ( Terminal half-life of the analyte in plasma)(up to 60 hours after drug administration)
- Number of patients with adverse events(up to 20 days after final drug administration)
研究者
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