NCT00803192已完成1 期
Randomized, 2-Way Crossover, Bioequivalence Study of Famotidine 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fed Conditions
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
- 44
- 主要终点
- Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity.
研究概览
简要总结
Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fed conditions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy men or women 18 years of age or older
- •body mass index below 30.0 kg/m2
- •willing to participate and sin a copy of the informed consent form
排除标准
- •recent history of drug or alcohol addiction or abuse
- •pregnant or lactating women
- •history of allergic response to heparin, famotidine, other H2-receptor antagonists, or other related drugs
- •evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
- •smoking more than 25 cigarettes per day
研究组 & 干预措施
Test Drug
Active Comparator
干预措施: Famotidine Tablets, 40 mg (Drug)
Reference Drug
Active Comparator
干预措施: Famotidine Tablets, 40 mg (Drug)
结局指标
主要结局
Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity.
次要结局
未报告次要终点
研究者
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