Bioequivalence of Ezetimibe Tablets in Healthy Subjects: A Single-dose and Two-period Crossover Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)0-∞
研究概览
简要总结
According to the relevant provisions of bioequivalence test, ezetimibe Tablets (test preparation, T, 10mg / tablet) provided by China Resources Saike Pharmaceutical Co., Ltd. were compared with Ezetrol ® (reference preparation, R, 10mg / tablet) produced by MSD Pharma (Singapore) Pte. Ltd. to evaluate the bioequivalence of single dose in healthy subjects under fasting and fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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, with appropriate sex ratio;
- •The body mass index is in the range of 19.0-26.0 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.
- •The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test and Nicotine test.
- •The subjects have no family planning within 3 months and could select contraceptive method.
- •Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
排除标准
- •Alanine aminotransferase >1.0×ULN ,Aspartate aminotransferase >1.0×ULN or Total bilirubin >1.0×ULN.
- •Subjects with allergic constitution.
- •Being allergy to the study medications, smoking, alcohol abuse.
- •Participation in another clinical trial within 3 months.
研究组 & 干预措施
ezetimibe Tablets
ezetimibe tablets test formulation at a single dose of 10 mg
干预措施: ezetimibe tablets (Drug)
ezetimibe tablets(Ezetrol ®)
ezetimibe tablets reference formulation at a single dose of 10 mg
干预措施: ezetimibe tablets(Ezetrol ®) (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)0-∞
时间窗: 90 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Peak Plasma Concentration (Cmax)
时间窗: 90 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
时间窗: 90 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
次要结局
- Incidence of Treatment-Emergent Adverse Events(90 days)
- Incidence of abnormal blood pressure(90 days)
- Incidence of abnormal temperature(90 days)
研究者
Cao Yu
Director, Head of Phase I clinical research center, Principal Investigator, Clinical Professor.
The Affiliated Hospital of Qingdao University