Bioequivalence Study of Compound Lisinopril Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
The bioavailability of compound lisinopril tablets (specification: lisinopril 10mg / amlodipine 5mg) developed by Sichuan shangrui biomedical Co., Ltd. was compared with that of reference compound lisinopril tablets (specification: lisinopril 10mg / amlodipine 5mg) produced by Hungary Gedeon Richter Pharmaceutical Co., Ltd.The bioequivalence of single dose of test preparation and reference preparation was evaluated in heathy 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
- •1.Healthy male and female aged over 18years 2.Subjects willing to provide written informed consent and to adhere to protocol requirements 3.Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)), males with minimum of 50 kg weight, females with minimum of 45kg weight.
- •4.Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination
排除标准
- •1.History or presence of significant cardiovascular, Urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder 2.Allergic constitution(Allergic to two or more substances) or hypersensitivity to investigational product 3.History or presence of significant gastrointestinal inflammation /ulcer. or other medical history affecting drug absorption 4.Use of any drugs or herbal medicine within 14 days prior to the first dose 5.Can not follow approved birth control methods (a double barrier method) from the screening（Female subjects from two weeks prior to the screening） till 3 months after the last dose
研究组 & 干预措施
Compound lisinopril tablets
a single oral of Compound lisinopril tablets test formulation( Lisinopril 10mg/Levamlodipine besylate 5mg)
干预措施: compound lisinopril tablet (Drug)
Compound lisinopril tablets(Lisonorm®)
a single oral of Compound lisinopril tablets reference formulation( Lisinopril 10mg/Levamlodipine besylate 5mg)
干预措施: compound lisinopril tablet(Lisonorm®) (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 90 days
Evaluate the Cmax of Lenopril and amlodipine for test preparation and reference preparation
次要结局
未报告次要终点