Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects

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

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 Overview

• Status: Completed
• Conditions: Therapeutic Equivalency
• Intervention / Treatment: Drug: Reference Irbesartan Tablet; Drug: Tested Irbesartan Tablet

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Affiliated Hospital of Qingdao University Phase I Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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 -

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Principal Investigator: Yu Cao, The Affiliated Hosptial of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2018
• Primary Completion (Actual): January 16, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Irbesartan
• Other Study ID Numbers: SZHB17-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No