Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

December 27, 2022 updated by: The Affiliated Hospital of Qingdao University

Study on the Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

This study was conducted to assess the bioequivalence of the ezetimibe tablet to Ezetrol ® in healthy Chinese volunteers and estimate the pharmacokinetic profiles of ezetimibe tablet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China
        • Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female subjects ≥18 years of age
  • The body mass index is in the range of 18.0-26.0 kg/m2 (including the critical value).
  • The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
  • Serum total cholesterol was between 2.9 and 5.0mmol/L (not including critical value).

Exclusion Criteria:

  • any medical history of cardiovascular, digestive, respiratory, nervous or ematological diseases
  • hepatic/renal impairment
  • abnormal vital signs
  • drug or alcohol abuse
  • smoking ≥5 cigarettes per day ,
  • donation(≥300ml) o
  • enrollment in other clinical trials during the 3 months prior to screening
  • allergic to ezetimibe or its excipients
  • any use of other prescription drugs or vitamins or caffeine/xanthine-rich beverages 48h prior to taking medication
  • lactating or pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ezetimibe tablet
ezetimibe tablet test formulation at a single dose of 10 mg
Drug: ezetimibe tablet
The subjects randomly received single oral administration of ezetimibe tablet 10 mg
Active Comparator: ezetimibe tablet(Ezetrol ®)
ezetimibe tablet reference formulation at a single dose of 10 mg
Drug: ezetimibe tablet(Ezetrol ®)
The subjects randomly received single oral administration of ezetimibe tablet (Ezetrol ®) 10 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax)
Time Frame: 80 days
Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax)
80 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration versus time curve (AUC)0-t
Time Frame: 80 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
80 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Qingdao University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2017

Primary Completion (Actual)

January 29, 2018

Study Completion (Actual)

March 7, 2018

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHX-BE-201703

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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