NCT00925704已完成1 期
A Phase I, Randomized, Open-Label, Three Period Cross-Over Study to Assess the Pharmacokinetics of Oral Calcitriol (ROCALTROL®) in Healthy Volunteers When Administered Alone or When Co-Administered With Lanthanum Carbonate (FOSRENOL®) or Sevelamer Carbonate (RENVELA®)
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
- Shire
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol
研究概览
简要总结
To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on the pharmacokinetics of oral calcitriol (ROCALTROL)
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
- 19 Years 至 45 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
Calcitriol
Active Comparator
干预措施: Calcitriol (Drug)
Lanthanum carbonate + calcitriol
Experimental
干预措施: Lanthanum carbonate + Calcitriol (Drug)
Sevelamer carbonate + calcitriol
Experimental
干预措施: Sevelamer carbonate + Calcitriol (Drug)
结局指标
主要结局
Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol
时间窗: pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose
This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.
次要结局
- Time of Maximum Plasma Concentration (Tmax) for Exogenous Calcitriol(pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose)
- Maximum Plasma Concentration (Cmax) for Exogenous Calcitriol(pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose)
研究者
研究点 (1)
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