Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects

Single Oral Administration, Randomized, Open, Crossover and Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pharmacokinetics; Safety
• Intervention / Treatment: Behavioral: Test Preparation-Reference preparation; Behavioral: Reference preparation-Test Preparation

Detailed Description

To investigate the in vivo pharmacokinetic characteristics of ezetimibe tablets (specification 10mg) in Chinese healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of ezetimibe tablets produced by Changzhou Pharmaceutical Factory Co., Ltd. and the licensee MSD Pharma (Singapore) PTE. Ltd. To study the safety of single oral ezetimibe tablets (specification 10mg) in Chinese healthy subjects.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yu Cao, Doctor; Phone Number: 18661809090; Email: caoyu1767@126.com
• Study Contact Backup: Name: Xin Li, Doctor; Phone Number: 15065327781; Email: dove1202@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female aged 18 and above.
• The body mass index is in the range of 18.6-28.5 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.
• 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.

Exclusion Criteria:

• Being allergy to the study medications, smoking, alcohol abuse.
• Participation in another clinical trial within 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test preparation; Ezetimibe tablets: specification: 10mg; Package specification: 7 pieces / plate, 1 plate / box; Produced and provided by Changzhou Pharmaceutical Factory Co., Ltd.	Behavioral: Test Preparation-Reference preparation; Under fasting conditions, subjects randomly divided into TR group were given one tablet of test preparation first, and then one tablet of reference preparation after cleaning period.
Active Comparator: Reference preparation; Ezetimibe Tablets：Ezetrol ®， Specification: 10mg, packaging specification: 10 pieces / plate, 1 plate / box; Licensee: MSD Pharma (Singapore) PTE. Ltd.	Behavioral: Reference preparation-Test Preparation; Under fasting conditions, subjects randomly divided into RT group were given one tablet of reference preparation first, and then one tablet of test preparation after cleaning period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	96 hours
Area under the plasma concentration versus time curve (AUC)0-t	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t	96 hours
Area under the plasma concentration versus time curve (AUC)0-∞	Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞	96 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of abnormal blood pressure	Monitor both systolic and diastolic blood pressure	33 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of abnormal temperature	Monitor the temperature	33 days
Incidence of abnormal pulse	Monitor the pulse	33 days
Incidence of abnormal electrocardiogram waveform	Electrocardiogram inspection	33 days

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Collaborators: Changzhou Pharmaceutical Factory Co., Ltd
• Investigators: Principal Investigator: Yu Cao, Doctor, National Medical Products Administration

Study record dates

Study Major Dates

• Study Start (Anticipated): May 26, 2022
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Ezetimibe
• Other Study ID Numbers: 22FWX-CZYZ-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The technical achievements (including but not limited to patent right and thesis publishing right) involved in this trial, clinical research materials and achievements are owned by Zhejiang onlycom Pharmaceutical Co., Ltd. With the written consent of Zhejiang onlycom Pharmaceutical Co., Ltd., all partners have the right to publish academic papers, and the Affiliated Hospital of Qingdao University, a clinical research institution, has the right to exchange research results in academic conferences or journals.
• IPD Sharing Time Frame: The data have been available on May 22, 2022. The duration has not been determined.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No