NCT02180477已完成1 期
Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation
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
- 9
- 主要终点
- AUC 0-72hr (Area under the concentration-time curve in plasma from zero time to 72 hours)
研究概览
简要总结
Study to investigate the relative bioavailability of UHAC 62 XX capsule and two different tablet formulations (TF1 and TF2), and to obtain data for rational design of a subsequent pivotal bioequivalence (BE) study between capsule and tablet formulations.
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 meloxicam and/or salicylate (aspirin) and/or Non-steroidal anti-inflammatory drugs (NSAIDs)
- •History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
- •History of alcohol or drug abuse
- •Participation to another trial with an investigational drug within 4 months prior to the administration
- •Whole blood donation more than 400 ml within 3 months prior to the administration
- •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 administration
- •Any medication within 10 days prior to the administration
- •Excessive physical activities within 7 days prior to the administration
- •Alcohol drinking within 3 days prior to the administration
- •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 TF1 tablet
Experimental
干预措施: UHAC 62 XX - TF1 tablet (Drug)
UHAC 62 XX TF1 tablet
Experimental
干预措施: UHAC 62 XX - TF2 tablet (Drug)
UHAC 62 XX TF1 tablet
Experimental
干预措施: UHAC 62 XX - capsules (Drug)
UHAC 62 XX TF2 tablet
Experimental
干预措施: UHAC 62 XX - TF1 tablet (Drug)
UHAC 62 XX TF2 tablet
Experimental
干预措施: UHAC 62 XX - TF2 tablet (Drug)
UHAC 62 XX TF2 tablet
Experimental
干预措施: UHAC 62 XX - capsules (Drug)
UHAC 62 XX capsule
Active Comparator
干预措施: UHAC 62 XX - TF1 tablet (Drug)
UHAC 62 XX capsule
Active Comparator
干预措施: UHAC 62 XX - TF2 tablet (Drug)
UHAC 62 XX capsule
Active Comparator
干预措施: UHAC 62 XX - capsules (Drug)
结局指标
主要结局
AUC 0-72hr (Area under the concentration-time curve in plasma from zero time to 72 hours)
时间窗: up to 72 hours after administration
Cmax (Maximum observed concentration in plasma)
时间窗: up to 72 hours after administration
次要结局
- tmax (Time to reach maximum concentration)(up to 72 hours after administration)
- t1/2 (Terminal half-life in plasma)(up to 72 hours after administration)
- AUC 0-infinity (Area under the concentration-time curve in plasma from zero time to infinity)(up to 72 hours after administration)
- Number of patients with adverse events(up to 14 days after last administration)
- MRT 0-t (Mean residence time in the body from zero time to the time of the last quantifiable drug concentration)(up to 72 hours after administration)
研究者
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