Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects

Therapeutic Equivalency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05786339
• Other study ID #: SZHB17-007
• Status: Completed
• Phase: Phase 1
• Start date: November 17, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: March 2023
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 15, 2019
• Est. primary completion date: January 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Therapeutic Equivalency

Intervention

Drug:
• Tested Irbesartan Tablet
T
• Reference Irbesartan Tablet
R

Locations

Country	Name	City	State
China	Affiliated Hospital of Qingdao University Phase I Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Evaluation of Peak Plasma Concentration	48hours
Primary	AUC0-t	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t	484hours
Primary	AUC0-8	Evaluation of Area under the plasma concentration versus time curve	48hours
Secondary	safety	Monitor all the adverse event	30days