NCT07292233进行中（未招募）1 期
A Randomized, Open-Label, Single-Dose, Two-Period, Crossover Phase I Clinical Study to Evaluate the Food Effect on the Pharmacokinetics of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax) of LPM787000048 in plasma
研究概览
简要总结
This is a randomized, open-label, single-dose, two-period, crossover study to assess the food effect on pharmacokinetics (PK) and safety of LY03020 in healthy subjects.
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
- None
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
- •Subjects sign informed consent voluntarily.
- •Male or female aged 18 to 45 years.
- •Body weight ≥ 50.0kg for male and ≥ 45.0kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2.
排除标准
- •Subjects have any clinically significant medical condition or chronic disease.
- •Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.
- •Subjects with a history of orthostatic hypotension or syncope.
- •Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.
- •Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.
- •Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.
- •Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to first dosing.
- •Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation.
- •Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody.
研究组 & 干预措施
fasted,fed
Experimental
Subjects will take LY03020 80mg under fasted conditions and after a standard high-fat breakfast in period 1 and 2 respectively.
干预措施: LY03020 (Drug)
fed,fasted
Experimental
Subjects will take LY03020 80mg after a standard high-fat breakfast and under fasted conditions in period 1 and 2 respectively.
干预措施: LY03020 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax) of LPM787000048 in plasma
时间窗: up to Day 12
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma
时间窗: up to Day 12
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma
时间窗: up to Day 12
次要结局
- Time to maximum observed concentration (Tmax) of LPM787000048 in plasma(up to Day 12)
- Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma(up to Day 12)
- Number of participants with adverse events (AEs).(up to Day 12)
研究者
研究点 (1)
Loading locations...
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