NCT01405118已完成1 期
A Phase 1, Open Labeled, Fixed Sequence Study To Estimate The Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers
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
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUCinf (Area under the plasma concentration-time profile from time zero extrapolated to infinite time) of metformin
研究概览
简要总结
This study will evaluate the potential effect of CP 690,550 on the pharmacokinetics of metformin, a probe drug for organic cationic transport.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Adult healthy male and/or female (of non child bearing potential) subjects.
排除标准
- •Subjects with clinically significant systemic and laboratory abnormalities.
- •Subjects with clinically significant infections within the past 3 months.
- •Women of child-bearing potential.
研究组 & 干预措施
Metformin/CP-690,550
Experimental
干预措施: Metformin/CP-690,550 (Drug)
结局指标
主要结局
AUCinf (Area under the plasma concentration-time profile from time zero extrapolated to infinite time) of metformin
时间窗: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
Cmax (Maximum plasma concentration) of metformin
时间窗: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
Clr (Renal clearance) of metformin
时间窗: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
次要结局
- AUClast (Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration) of metformin(0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4)
- t½ (Terminal half-life) of metformin(0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4)
- Tmax (Time for maximum plasma concentration) of metformin(0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4)
- Ae24 (Cumulative amount of drug recovered unchanged in urine from time zero to 24 hours postdose) of metformin(0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4)
- Ae24% (Percent of dose recovered unchanged in urine from time zero to 24 hours postdose) of metformin(0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4)
- Clr (Renal clearance) over each collection interval for metformin(0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4)
- CP-690,550 plasma concentration at 2 hours postdose(2 hrs after first CP-690,550 dose on Day 4)
研究者
研究点 (1)
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