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Bioequivalence Study of Ezetimibe Tablets Under Fed Conditions in Healthy Subjects

NCT05481385 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-08-01

No results posted yet for this study

Summary

The fed bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.

Conditions

  • Pharmacokinetics
  • Safety

Interventions

BEHAVIORAL

Reference preparation-Reference preparation-Test Preparation

Under fed conditions, subjects randomly divided into RRT group were given one tablet of reference preparation first, and then one tablet of reference preparation after cleaning period, and then one tablet of test preparation after cleaning period.

BEHAVIORAL

Reference preparation-Test Preparation-Reference preparation

Under fed conditions, subjects randomly divided into RTR group were given one tablet of reference preparation first, and then one tablet of test preparation after cleaning period, and then one tablet of reference preparation after cleaning period.

BEHAVIORAL

Test Preparation-Reference preparation-Reference preparation

Under fed conditions, subjects randomly divided into RTR group were given one tablet of test preparation first, and then one tablet of reference preparation after cleaning period, and then one tablet of reference preparation after cleaning period.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2022-08-31
Completion
2022-12-30

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 NCT05481385 on ClinicalTrials.gov