NCT06372223已完成1 期
A Single-center, Randomized, Open, Single-dose, Two-cycle, Two-sequence Crossover Food Effect Study of SPH5030 Tablets in Healthy Chinese Adult Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 交叉
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Fully informed subjects who voluntarily sign the ICF；
- Females who are not pregnant, non-lactating. Subjects who complied with the contraceptive requirements of the protocol.
排除标准
- Subjects with any medical history assessed by the investigator that unsuitable for participation in a clinical study;
- Subjects with abnormal test results during the screening period；
- Subjects who have difficulty in venous blood collection;
- Subjects who cannot accept uniform diet or have difficulty swallowing;
- Other situations that meet the exclusion criteria.
研究组 & 干预措施
Group A
Experimental
干预措施: SPH5030 (Drug)
Group B
Experimental
干预措施: SPH5030 (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: Approximately 2 months
PK（Pharmacokinetics）
Peak time（Tmax）
时间窗: Approximately 2 months
PK（Pharmacokinetics）
Area under the plasma concentration versus time curve (AUC)
时间窗: Approximately 2 months
PK（Pharmacokinetics）
次要结局
- Incidence of Treatment-Emergent Adverse Events(Approximately 2 months)
研究者
研究点 (1)
Loading locations...
标识符
- NCT 编号
- NCT06372223
- 其他研究编号
- SPH5030-102
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (2年前)
- 研究完成日期
- (2年前)
- 最近核实
- 最近更新
- (2年前)
监管与共享
- FDA 监管药物
- 否
- 是否有结果
- 否
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