NCT00883883已完成1 期
A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 250mg/5 ml Cefdinir (Test Formulation) and Omnicel 250mg/5 ml Powder For Oral Suspension (Reference Formulation) Each Given as a Single Oral Dose to Forty Healthy Male and/or Female Volunteers in the Fed State
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
- Sandoz
- 入组人数
- 40
- 主要终点
- Bioequivalence based on AUC and Cmax
研究概览
简要总结
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250 mg/5 ml 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 56 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
排除标准
- •Positive test results for HIV or hepatitis B or C.
- •Treatment for drug or alcohol dependence.
研究组 & 干预措施
1
Experimental
Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)
干预措施: Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria) (Drug)
2
Active Comparator
Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)
干预措施: Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA) (Drug)
结局指标
主要结局
Bioequivalence based on AUC and Cmax
时间窗: 15 days
次要结局
未报告次要终点
研究者
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