Bioequivalence Study of Ezetimibe Tablets Under Fed Conditions in Healthy Subjects

Phase 1

• Conditions: Pharmacokinetics; Safety
• Interventions: Behavioral: Test Preparation-Reference preparation-Reference preparation; Behavioral: Reference preparation-Reference preparation-Test Preparation; Behavioral: Reference preparation-Test Preparation-Reference preparation

• Registration Number: NCT05481385
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief 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.

Detailed Description

To investigate the in vivo pharmacokinetic characteristics of ezetimibe tablets (specification 10mg) in Chinese healthy subjects after a single oral administration under fed 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 Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-15
• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-08-01
• Last Update Posted: 2022-08-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

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Exclusion Criteria

• • Being allergy to the study medications, smoking, alcohol abuse.

  • Participation in another clinical trial within 3 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test preparation	Test Preparation-Reference preparation-Reference preparation	Ezetimibe tablets: specification: 10mg; Package specification: 7 pieces / plate, 1 plate / box; Produced and provided by Changzhou Pharmaceutical Factory Co., Ltd.
Reference preparation	Reference preparation-Test Preparation-Reference preparation	Ezetimibe Tablets Ezetrol ®; Specification: 10mg, packaging specification: 10 pieces / plate, 1 plate / box; Licensee: MSD Pharma (Singapore) PTE. Ltd
Reference preparation	Reference preparation-Reference preparation-Test Preparation	Ezetimibe Tablets Ezetrol ®; Specification: 10mg, packaging specification: 10 pieces / plate, 1 plate / box; Licensee: MSD Pharma (Singapore) PTE. Ltd

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of abnormal temperature	33 days	Monitor the temperature
Incidence of abnormal blood pressure	33 days	Monitor both systolic and diastolic blood pressure
Incidence of abnormal pulse	33 days	Monitor the pulse
Incidence of abnormal electrocardiogram waveform	33 days	Electrocardiogram inspection

Trial Locations

Locations (1)

Phase I clinical research center; 🇨🇳 Qingdao, Shandong, China