NCT05360628已完成早期 1 期
A Phase I, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic Interactions Between D-0120 and Allopurinol in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Type, incidence, severity and attribution of AEs.
研究概览
简要总结
Evaluation of safety and PK interaction between D-0120 and Alopurinol in healthy adult subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Healthy subjects between the ages of 18-55
- •Required evaluation by Investigator for screening and enrollment
- •Agreement and compliance with the study and follow-up procedures
排除标准
- •Significant medical history or current comorbidly determined by the Investigator.
- •Pregnant or nursing women
研究组 & 干预措施
D-0120 plus Allopurinol
Experimental
D-0120 dosing followed by Allopurinol and combination treatment
干预措施: D-0120 in combination with Allopurinol (Drug)
Allopurinol plus D-0120
Experimental
Allopurinol dosing followed by D-0120 and combination treatment
干预措施: D-0120 in combination with Allopurinol (Drug)
结局指标
主要结局
Type, incidence, severity and attribution of AEs.
时间窗: 14 days
Evaluation of safety between D-0120 and Allopurinol
Plasma concentration of D-0120 and Allopurinol
时间窗: 14 days
Evaluation of exposure between D-0120 and Allopurinol
次要结局
未报告次要终点
研究者
研究点 (1)
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