NCT01405131撤回1 期
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2 Period Crossover Bioequivalence Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fasted Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- AUCinf (area under the concentration curve to infinity)
研究概览
简要总结
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets.
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects between the ages of 21 and 55 years.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight > 45 kg (99 lbs).
排除标准
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen
研究组 & 干预措施
methylprednisolone suspension
Experimental
干预措施: methylprednisolone (Drug)
methylprednisolone tablets
Active Comparator
干预措施: methylprednisolone (Drug)
结局指标
主要结局
AUCinf (area under the concentration curve to infinity)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Cmax (maximum concentration)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
次要结局
- AUC last (area under the concentration curve to last time point)(0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose)
- Tmax (time at maximum concentration)(0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose)
- Half-life(0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose)
研究者
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进行中（未招募）
不适用
Randomized study with methylprednisolone 1mg/kg/day for treatment of grade I acute GvHDpatients developing acute GvHD grade IMedDRA version: 14.1Level: LLTClassification code 10000802Term: Acute GVH diseaseSystem Organ Class: 100000004870EUCTR2008-000413-29-ITGITMO GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO,CELLULE STAMINALI EMOPOIETICHE E TERAPIA CELLULARE - ONLUS