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Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects

Sponsor
The Affiliated Hospital of Qingdao University (Other)
Overall Status
Completed
CT.gov ID
NCT05786339
Collaborator
(none)
68
Enrollment
1
Location
2
Arms
5.9
Actual Duration (Months)
11.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tested Irbesartan Tablet
  • Drug: Reference Irbesartan Tablet
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects: an Open, Randomized, Single-Dose and Crossover Study
Actual Study Start Date :
Nov 17, 2018
Actual Primary Completion Date :
Jan 16, 2019
Actual Study Completion Date :
May 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Cmax [48hours]

    Evaluation of Peak Plasma Concentration

  2. AUC0-t [484hours]

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

  3. AUC0-∞ [48hours]

    Evaluation of Area under the plasma concentration versus time curve

Secondary Outcome Measures

  1. safety [30days]

    Monitor all the adverse event

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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 -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated Hospital of Qingdao University Phase I Clinical Research Center Qingdao Shandong China 266003

Sponsors and Collaborators

  • The Affiliated Hospital of Qingdao University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Affiliated Hospital of Qingdao University
ClinicalTrials.gov Identifier:
NCT05786339
Other Study ID Numbers:
  • SZHB17-007
First Posted:
Mar 27, 2023
Last Update Posted:
Mar 27, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Irbesartan

Study Results

No Results Posted as of Mar 27, 2023