NCT05681247已完成1 期
Study on the Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy 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
- 59
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax)
研究概览
简要总结
This study was conducted to assess the bioequivalence of the ezetimibe tablet to Ezetrol ® in healthy Chinese volunteers and estimate the pharmacokinetic profiles of ezetimibe tablet.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects ≥18 years of age
- •The body mass index is in the range of 18.0-26.0 kg/m2 (including the critical value).
- •The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
- •Serum total cholesterol was between 2.9 and 5.0mmol/L (not including critical value).
排除标准
- •any medical history of cardiovascular, digestive, respiratory, nervous or ematological diseases
- •hepatic/renal impairment
- •abnormal vital signs
- •drug or alcohol abuse
- •smoking ≥5 cigarettes per day ,
- •donation(≥300ml) o
- •enrollment in other clinical trials during the 3 months prior to screening
- •allergic to ezetimibe or its excipients
- •any use of other prescription drugs or vitamins or caffeine/xanthine-rich beverages 48h prior to taking medication
- •lactating or pregnant women
研究组 & 干预措施
ezetimibe tablet
Experimental
ezetimibe tablet test formulation at a single dose of 10 mg
干预措施: ezetimibe tablet (Drug)
ezetimibe tablet(Ezetrol ®)
Active Comparator
ezetimibe tablet reference formulation at a single dose of 10 mg
干预措施: ezetimibe tablet(Ezetrol ®) (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax)
时间窗: 80 days
Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax)
次要结局
- Area under the plasma concentration versus time curve (AUC)0-t(80 days)
研究者
研究点 (1)
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