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

NCT05297929 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-03-28

No results posted yet for this study

Summary

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

Conditions

  • Irbesartan Tablets (0.15g/Tablet)
  • Under Fasted Condition
  • Under Fed Condition
  • Bioequivalence

Interventions

DRUG

Irbesartan Tablet

Drug: Irbesartan Oral administration on an empty stomach／fed condition

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Principal Investigators

  • Yu Cao, professor · The Affiliated Hospital of Qingdao University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-17
Primary Completion
2022-04-09
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05297929 on ClinicalTrials.gov