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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05786339

Enrollment

Registered

2023-03-27

Start date

2018-11-17

Completion date

2019-05-15

Last updated

2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Therapeutic Equivalency

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.

Interventions

DRUGTested Irbesartan Tablet

DRUGReference Irbesartan Tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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 -

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
safety	30days	Monitor all the adverse event

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026