NCT00601575已完成不适用
A Single Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bioequivalence
研究概览
简要总结
The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fed conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.
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
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
排除标准
- •Participation in a clinicl trial within 30 days prior to study initiation.
- •Positive test for HIV, Hepatitis B, or Hepatitis C.
- •Treatment with known enzyme altering drugs.
结局指标
主要结局
Bioequivalence
时间窗: Baseline, Three period, Fourteen day washout
次要结局
未报告次要终点
研究者
研究点 (1)
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