NCT00925106已完成1 期
A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Celecoxib Formulations D1, D2 And D3 In Healthy Volunteers
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUCinf, AUCt, Cmax
研究概览
简要总结
The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteers
- •Body weight BMI 17.5-30.5
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
- •Positive urine drug screen
研究组 & 干预措施
Celebrex capsule
Active Comparator
Commercial capsule
干预措施: Celebrex capsule (Drug)
D1
Experimental
Test formulation D1
干预措施: Test formulation D1 (Drug)
D2
Experimental
Test formulation D2
干预措施: Test formulation D2 (Drug)
D3
Experimental
Test formulation D3
干预措施: Test formulation D3 (Drug)
结局指标
主要结局
AUCinf, AUCt, Cmax
时间窗: 1.5 month
Visual inspection of median plasma concentration versus time profiles resulting from each formulation
时间窗: 1.5 month
次要结局
- adverse events, laboratory tests, vital signs(1.5 month)
- Tmax, half-life(1.5 month)
研究者
研究点 (1)
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