A Bioequivalence Trial of Irbesartan Tablets（0.15g） in Healthy Chinese Subjects

Bioequivalence of Irbesartan Tablets (0.15g/Tablet) in a Randomized, Open, Two-cycle, Two-crossover Single Fasting/Postprandial State in Healthy Subjects

To study the pharmacokinetics of test preparation and reference preparation irbesartan tablets (0.15g/tablet) in a single oral administration in fasting and fed state,respectively, in healthy adult subjects, and to evaluate the bioequivalence of the two preparations

Study Overview

• Status: Recruiting
• Conditions: Bioequivalence; Irbesartan Tablets (0.15g/Tablet); Under Fasted Condition; Under Fed Condition
• Intervention / Treatment: Drug: Irbesartan Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • The affiliated hospital of Qingdao university
      • Contact: Yu Cao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male and female subjects aged 18 to 45 years (inclusive);
2. Male subjects not less than 50 kg weight, women were not less than 45 kg weight. Scope of body mass index (BMI) of 19.0 ~ 26.0 kg/m2 / BMI = weight (kg)/height (m) 2] (including 19.0 and 26.0);
3. Have the ability to communicate with normal researchers/staff and comply with the relevant provisions on the administration of hospital;
4. The subject fully understands the purpose, nature, methods and possible adverse reactions of the test, voluntarily acts as a subject, and signs an informed consent before the start of any study program;
5. Participants must agree on the non-drug contraception and begin screening and the last time the medicine to prevent pregnancy or within 6 months after with couple of pregnancy.

Exclusion Criteria:

1. The respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, spirit, system and metabolic abnormalities any clinical history of serious illness, or any other disease which can interfere with the test results or physiological conditions and the researchers judged as abnormal have clinical significance;
2. The physical examination, vital signs, abnormal electrocardiogram (ecg) and laboratory examination (unless approved by the researchers determine abnormal no clinical significance).
3. Have difficulty swallowing or any affect drug absorption of gastrointestinal diseases history or has a history of digestive surgery, hemorrhoids surgery (appendix except and abdomen ditch hernia repair surgery) or affect the pharmacokinetic factors are known;
4. A history of orthostatic hypotension or screening phase orthostatic hypotension;
5. In the past year of alcohol abuse, such as drinking more than 14 units of alcohol a week (1 unit of alcohol is equal to 360 ml 150 ml beer or wine or 45 ml 40% distillation wine, such as the spirit Erguotou, etc.) or the whole experiments cannot stop drinkers;
6. 3 months prior to screening the average daily amount of more than 5 pieces, or cannot be confirmed and agreed to the first cycle dosing 48 hours before the last time to collect blood before smoking;
7. Human immunodeficiency virus (HIV), hepatitis b surface antigen, treponema pallidum antibody or hepatitis c virus (HCV) antibody is positive;
8. Alcohol breath test or drug abuse inspection is positive;
9. The first cycle within 3 months before the treatment, attend a group into any clinical trials;
10. Within a month before the first cycle to use any other drugs, including prescription drugs or over-the-counter medications (including oral multivitamins, herb medicine, Chinese medicine, medicine stewed food or dietary supplements);
11. Subjects were unable to confirm and agree with the first cycle 48 hours before delivery to the front of the last blood ban suits oranges, grapefruits, grapefruit, pomelo, orange, or any alcoholic, xanthine and caffeine foods and beverages, including chocolate, tea, coffee, coke, etc.);
12. This product and its analogues, or to any known a complementary makings allergy, or appeared to two or more drugs, such as food allergies or allergic constitution;
13. There are galactose intolerance, total lactase deficiency or glucose - galactose malabsorption of rare genetic disease;
14. Cannot accept venous blood collection or meals provided by the clinical trial center;
15. Drug delivery within one month before the first cycle vaccinated;
16. The first cycle for three months before donating blood or blood loss is equal to or more than 400 mL;
17. Pregnant or breastfeeding women, or screening in the first two weeks of women with and without protective behavior;
18. The researchers determine the subjects are not suitable for participating in this study or for other reasons can not complete the study subjects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Reference formulation; Irbesartan tablet (0.15g/tablet) , Manufacturer: Sanofi Winthrop Industries	Drug: Irbesartan Tablet; Drug: Irbesartan Oral administration on an empty stomach／fed condition
Experimental: Experimental: Test formulation; Irbesartan tablet (0.15g/tablet) , Manufacturer: Zhejiang Hua Hai Pharmaceutical Co. LTD	Drug: Irbesartan Tablet; Drug: Irbesartan Oral administration on an empty stomach／fed condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t	Pharmacokinetic parameter AUC0-t estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan	up to 1 year
AUC0-∞	Pharmacokinetic parameter AUC0-∞ estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan	up to 1 year
Cmax	Pharmacokinetic parameter Cmax estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan	up to 1 year
Tmax	Pharmacokinetic parameter Tmax estimated by non-compartmental analysis model based on the plasma concentration data of concentration data of irbesartan	up to 1 year
bioequivalence	Analysis of variance (ANOVA) was performed after logarithmic conversion of main pharmacokinetic parameters (Cmax, AUC) to calculate 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters of the two preparations, and equivalence comparison was conducted. The equivalent interval was set to 80.00%~125.00%	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE	Number of participants with treatment-related adverse events as assessed by CTCAE	up to 6 months

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Principal Investigator: Yu Cao, professor, The affiliated hospital of Qingdao university

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Anticipated): April 9, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 6, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Irbesartan
• Other Study ID Numbers: BJK-BE-EBST-2021017-ZJHH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No