NCT04814589

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 22, 2021

Last Update Submit

March 22, 2021

Conditions

Therapeutic Equivalency

Outcome Measures

Primary Outcomes (3)

  • Peak Plasma Concentration (Cmax)

    Evaluation of Peak Plasma Concentration (Cmax)

    90 days

  • Area under the plasma concentration versus time curve (AUC)0-t

    Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

    90 days

  • Area under the plasma concentration versus time curve (AUC)0-∞

    Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞

    90 days

Secondary Outcomes (3)

  • Incidence of Treatment-Emergent Adverse Events

    90 days

  • Incidence of abnormal blood pressure

    90 days

  • Incidence of abnormal temperature

    90 days

Study Arms (2)

ezetimibe Tablets

EXPERIMENTAL

ezetimibe tablets test formulation at a single dose of 10 mg

Drug: ezetimibe tablets

ezetimibe tablets(Ezetrol ®)

ACTIVE COMPARATOR

ezetimibe tablets reference formulation at a single dose of 10 mg

Drug: ezetimibe tablets(Ezetrol ®)

Interventions

ezetimibe tabletsDRUG

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

ezetimibe Tablets
ezetimibe tablets(Ezetrol ®)DRUG

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

ezetimibe tablets(Ezetrol ®)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female subjects ≥18 years of age, with appropriate sex ratio;
  • The body mass index is in the range of 19.0-26.0 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.
  • The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test and Nicotine test.
  • The subjects have no family planning within 3 months and could select contraceptive method.
  • Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

You may not qualify if:

  • Alanine aminotransferase \>1.0×ULN ,Aspartate aminotransferase \>1.0×ULN or Total bilirubin \>1.0×ULN.
  • Subjects with allergic constitution.
  • Being allergy to the study medications, smoking, alcohol abuse.
  • Participation in another clinical trial within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phase Ⅰ Clinical Research Center

Qingdao, Shandong, 266003, China

RECRUITING

MeSH Terms

Interventions

Ezetimibe

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • yu Cao, doctor

    the study director of phase I clinical research center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

yu Cao, doctor

CONTACT

86 18661809090caoyu1767@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Head of Phase I clinical research center, Principal Investigator, Clinical Professor.

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 24, 2021

Study Start

March 13, 2021

Primary Completion

June 30, 2021

Study Completion

July 31, 2021

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)