NCT01052987已完成2 期
A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Allopurinol Compared With Tranilast Alone and Allopurinol Alone in Healthy Subjects With Hyperuricemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean percent decrease in serum uric acid levels
研究概览
简要总结
This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period 2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of allopurinol on tranilast PK and PD as measured by reduction in serum uric acid levels.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 21 to 70
- •Subjects with hyperuricemia who are otherwise healthy
排除标准
- •Pregnant or nursing
- •Known history of gout unless approved by the Investigator or Sponsor
- •Clinically significant infection at Screening
- •Known sensitivity to tranilast or allopurinol
研究组 & 干预措施
Tranilast
Experimental
Tranilast tablets
干预措施: Tranilast (Drug)
Allopurinol
Active Comparator
Allopurinol tablets
干预措施: Allopurinol (Drug)
Combination
Experimental
Tranilast plus Allopurinol
干预措施: Combination - Tranilast and Allopurinol (Drug)
High dose Allopurinol
Active Comparator
400 mg Allopurinol
干预措施: 400 mg Allopurinol (Drug)
High dose combination
Experimental
Combination of Tranilast 300 mg and Allopurinol 400 mg
干预措施: High dose combination (Drug)
结局指标
主要结局
Mean percent decrease in serum uric acid levels
时间窗: Seven days
次要结局
- Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination(Seven days)
研究者
研究点 (1)
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