NCT00821444已完成1 期
Phase 1 Study Of Ziprasidone Pharmacokinetics Of Reduced Food Effect Formulation B16 Under Fed And Fasting Conditions Compared To Commercial Geodon Capsules Under Fed Conditions In Healthy Subjects
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 11 人开始时间: 2009年1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
- 11
- 试验地点
- 1
- 主要终点
- Relative bioavailability measured as geometric mean ratios of AUCinf and Cmax and the associated 90% confidence intervals calculated for various pairs of study treatments.
研究概览
简要总结
Commercial ziprasidone capsules show a large increase in bioavailability with food. The formulation tested in this study aims to reduce or eliminate that increase.
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 subjects
- •Signed informed consent document
排除标准
- •Any significant physical or psychological disease
- •Concomitant administration of other pharmaceuticals
研究组 & 干预措施
Geodon fed
Active Comparator
Commercial Geodon (ziprasidone) capsules given with food
干预措施: ziprasidone (Drug)
B16 Fasted
Experimental
Experimental reduced food effect formulation given without food
干预措施: B16 Fasted (Drug)
B16 Fed
Experimental
Experimental reduced food effect formulation given with food
干预措施: B16 Fed (Drug)
结局指标
主要结局
Relative bioavailability measured as geometric mean ratios of AUCinf and Cmax and the associated 90% confidence intervals calculated for various pairs of study treatments.
时间窗: 2 months
次要结局
- Adverse events reported, laboratory test results, vital signs observed with each study treatment(2 months)
研究者
研究点 (1)
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