NCT00880750已完成1 期
A Phase I Pharmacodynamic Equivalence Study Comparing Urinary Phosphate Excretion and Plasma Lanthanum Pharmacokinetics for a Lanthanum Carbonate Granule Formulation and Chewable Tablets Administered to Healthy Adult Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Urinary Phosphate Excretion 3-Day Average
研究概览
简要总结
This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lanthanum carbonate granules
Experimental
Lanthanum carbonate granulated formulation crossover to chewable tablet formulation
干预措施: Lanthanum carbonate Granule Formulation (Drug)
Lanthanum carbonate chewable tablets (Fosrenol)
Experimental
Lanthanum carbonate chewable table formulation crossover to granulated formulation
干预措施: Lanthanum carbonate Chewable Tablets (Fosrenol) (Drug)
结局指标
主要结局
Urinary Phosphate Excretion 3-Day Average
时间窗: Continuous collection over 3 days
次要结局
- Urinary Phosphate Excretion on Day 4(Continuous collection on Day 4)
- Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate(3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4)
- Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate(3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4)
- Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate(3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4)
研究者
研究点 (1)
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