Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects

Phase 1

Completed

• Conditions: Therapeutic Equivalency
• Interventions: Drug: Reference Irbesartan Tablet; Drug: Tested Irbesartan Tablet

• Registration Number: NCT05786339
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-17
• Primary Completion: 2019-01-16
• Study Completion: 2019-05-15
• Study First Submitted: 2023-02-03
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-24
• Last Update Submitted: 2023-03-24
• Study First Posted: 2023-03-27
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

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Exclusion Criteria

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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference formulation	Reference Irbesartan Tablet	Irbesartan tablet (0.15g/tablet) , Manufacturer: Sanofi Clir SNC
Test formulation	Tested Irbesartan Tablet	Irbesartan tablet (0.15g/tablet) , Manufacturer: Shenzhen Haibin Pharmaceutical Co., Ltd.

Primary Outcome Measures

Name	Time	Method
Cmax	48hours	Evaluation of Peak Plasma Concentration
AUC0-t	484hours	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
AUC0-∞	48hours	Evaluation of Area under the plasma concentration versus time curve

Secondary Outcome Measures

Name	Time	Method
safety	30days	Monitor all the adverse event

Trial Locations

Locations (1)

Affiliated Hospital of Qingdao University Phase I Clinical Research Center; 🇨🇳 Qingdao, Shandong, China