Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects: an Open, Randomized, Single-Dose and Crossover Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Cmax
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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 -
Arms & Interventions
Reference formulation
Irbesartan tablet (0.15g/tablet) , Manufacturer: Sanofi Clir SNC
Intervention: Reference Irbesartan Tablet (Drug)
Test formulation
Irbesartan tablet (0.15g/tablet) , Manufacturer: Shenzhen Haibin Pharmaceutical Co., Ltd.
Intervention: Tested Irbesartan Tablet (Drug)
Outcomes
Primary Outcomes
Cmax
Time Frame: 48hours
Evaluation of Peak Plasma Concentration
AUC0-t
Time Frame: 484hours
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
AUC0-∞
Time Frame: 48hours
Evaluation of Area under the plasma concentration versus time curve
Secondary Outcomes
- safety(30days)