Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects: an Open, Randomized, Single-Dose and Crossover Study

Conditions
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Therapeutic Equivalency

Intervention / Treatment
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* Drug: Tested Irbesartan Tablet
* Drug: Reference Irbesartan Tablet


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reference formulation<br>Irbesartan tablet (0.15g/tablet) , Manufacturer: Sanofi Clir SNC | Drug: Reference Irbesartan Tablet<br>* R<br>|
| Experimental: Test formulation<br>Irbesartan tablet (0.15g/tablet) , Manufacturer: Shenzhen Haibin Pharmaceutical Co., Ltd. | Drug: Tested Irbesartan Tablet<br>* T<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Evaluation of Peak Plasma Concentration | 48hours | 
| AUC0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 484hours | 
| AUC0-∞ | Evaluation of Area under the plasma concentration versus time curve | 48hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | Monitor all the adverse event | 30days |