NCT05677035已完成1 期
A Single-center, Open-label, Parallel-group, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LINO-1713 in Healthy Korean Female Subjects
Hyundai Pharm1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetics parameters: Cmax
研究概览
简要总结
A single-center, open-label, parallel-group, phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of LINO-1713 in healthy Korean female subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a Body Mass Index (BMI) between 18kg/m2 ~ 28kg/m2
排除标准
- •Clinically significant cardiovascular disease, respiratory disease
研究组 & 干预措施
Pharmacokinetic evaluation
Experimental
LINO-1713 (Estetrol 15mg/Drospirenone 3mg)
干预措施: LINO-1713 1 tablet (Drug)
Pharmacodynamic evaluation
Experimental
LINO-1713 (Estetrol 15mg/Drospirenone 3mg)
干预措施: LINO-1713 once a day for 24 days (Drug)
结局指标
主要结局
Pharmacokinetics parameters: Cmax
时间窗: Before and after administration 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, and 168 hours
Pharmacokinetics parameters: Tmax
时间窗: Before and after administration 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, and 168 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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