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OpenTrials
Completed

NCT Number: NCT05786339

Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects

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.

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Key information

Conditions

Therapeutic Equivalency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Affiliated Hospital of Qingdao University Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Tested Irbesartan Tablet

Drug

T

Reference Irbesartan Tablet

Drug

R

Primary outcomes

  1. Cmax

    Time frame: 48hours

    Evaluation of Peak Plasma Concentration

  2. AUC0-t

    Time frame: 484hours

    Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

  3. AUC0-∞

    Time frame: 48hours

    Evaluation of Area under the plasma concentration versus time curve

Secondary outcomes

  1. safety

    Time frame: 30days

    Monitor all the adverse event

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2023
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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