Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects

NCT05786339 | Completed Phase 1

• 1 other identifier: SZHB17-007
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Therapeutic Equivalency

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• safety

  30days

Study Arms (2)

Reference formulation

EXPERIMENTAL

Irbesartan tablet (0.15g/tablet) , Manufacturer: Sanofi Clir SNC

Drug: Reference Irbesartan Tablet

Test formulation

EXPERIMENTAL

Irbesartan tablet (0.15g/tablet) , Manufacturer: Shenzhen Haibin Pharmaceutical Co., Ltd.

Drug: Tested Irbesartan Tablet

Interventions

Tested Irbesartan Tablet DRUG

T

Test formulation

Reference Irbesartan Tablet DRUG

R

Reference formulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Affiliated Hospital of Qingdao University Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

Location

Study Officials

• Yu Cao

  The Affiliated Hosptial of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: March 27, 2023
• Study Start: November 17, 2018
• Primary Completion: January 16, 2019
• Study Completion: May 15, 2019
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)