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Bioequivalence of Ezetimibe Tablets in Healthy Subjects

NCT04814589 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-03-24

No results posted yet for this study

Summary

According to the relevant provisions of bioequivalence test, ezetimibe Tablets (test preparation, T, 10mg / tablet) provided by China Resources Saike Pharmaceutical Co., Ltd. were compared with Ezetrol ® (reference preparation, R, 10mg / tablet) produced by MSD Pharma (Singapore) Pte. Ltd. to evaluate the bioequivalence of single dose in healthy subjects under fasting and fed conditions.

Conditions

  • Therapeutic Equivalency

Interventions

DRUG

ezetimibe tablets

The subjects randomly received single oral administration of ezetimibe tablets 10 mg.

DRUG

ezetimibe tablets(Ezetrol ®)

The subjects randomly received single oral administration of ezetimibe tablets 10 mg.

Sponsors & Collaborators

  • Cao Yu

    lead OTHER

Principal Investigators

  • yu Cao, doctor · the study director of phase I clinical research center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-13
Primary Completion
2021-06-30
Completion
2021-07-31

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 NCT04814589 on ClinicalTrials.gov