NCT03375632已完成1 期
Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout
Mochida Pharmaceutical Company, Ltd.1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年1月4日最近更新:
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
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pharmacodynamics (Amount of uric acid excreted in urine)
研究概览
简要总结
To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Serum urate level:
- •>= 7.0mg/dL in patients with gouty nodule or with history of gout, or >=8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL
- •Disease type in the classification of hyperuricemia: Uric acid-overproduction type or Uric acid-underexcretion type
- •Outpatients
排除标准
- •Gouty arthritis within 14 days before randomized allocation
研究组 & 干预措施
Uric acid-overproduction Type
Experimental
干预措施: FYU-981 (Drug)
Uric acid-underexcretion Type
Experimental
干预措施: FYU-981 (Drug)
结局指标
主要结局
Pharmacodynamics (Amount of uric acid excreted in urine)
时间窗: 14-week
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Clinical Pharmacology of FYU-981 (Elder Subjects)HealthyNCT02344875Fuji Yakuhin Co., Ltd.24
已完成
2 期
Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)HyperuricemiaNCT02837198Fuji Yakuhin Co., Ltd.24
已完成
1 期
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)HealthyHepatic InsufficiencyNCT03306667Mochida Pharmaceutical Company, Ltd.24
已完成
1 期
Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)HealthyRenal InsufficiencyNCT02347046Fuji Yakuhin Co., Ltd.18
已完成
1 期
Single Dose Phase I Study of FYU-981HealthyNCT02348307Fuji Yakuhin Co., Ltd.54