Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects: an Open, Randomized, Single-Dose and Crossover Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The bioavailability of Irbesartan (150 mg) developed by Shenzhen Haibin Pharmaceutical Co., Ltd. was compared with that of reference Irbesartan (Aprovel ®,150 mg) produced by Sanofi Clir SNC. 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
- •Healthy male and female aged over 18years
- •Subjects willing to provide written informed consent and to adhere to protocol requirements
- •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.
- •Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination
排除标准
- •History or presence of significant cardiovascular, Urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder
- •Allergic constitution(Allergic to two or more substances) or hypersensitivity to investigational product
- •History or presence of significant gastrointestinal inflammation /ulcer. or other medical history affecting drug absorption
- •Use of any drugs or herbal medicine within 14 days prior to the first dose
- •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
Reference formulation
Irbesartan tablet (0.15g/tablet) , Manufacturer: Sanofi Clir SNC
干预措施: Reference Irbesartan Tablet (Drug)
Test formulation
Irbesartan tablet (0.15g/tablet) , Manufacturer: Shenzhen Haibin Pharmaceutical Co., Ltd.
干预措施: Tested Irbesartan Tablet (Drug)
结局指标
主要结局
Cmax
时间窗: 48hours
Evaluation of Peak Plasma Concentration
AUC0-t
时间窗: 484hours
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
AUC0-∞
时间窗: 48hours
Evaluation of Area under the plasma concentration versus time curve
次要结局
- safety(30days)