Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Phase 1

• Conditions: Therapeutic Equivalency
• Interventions: Drug: ezetimibe tablets; Drug: ezetimibe tablets(Ezetrol ®)

• Registration Number: NCT04814589
• Lead Sponsor: Cao Yu

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-13
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Last Update Submitted: 2021-03-22
• Study First Posted: 2021-03-24
• Last Update Posted: 2021-03-24
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ezetimibe Tablets	ezetimibe tablets	ezetimibe tablets test formulation at a single dose of 10 mg
ezetimibe tablets(Ezetrol ®)	ezetimibe tablets(Ezetrol ®)	ezetimibe tablets reference formulation at a single dose of 10 mg

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)0-t	90 days	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Area under the plasma concentration versus time curve (AUC)0-∞	90 days	Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Peak Plasma Concentration (Cmax)	90 days	Evaluation of Peak Plasma Concentration (Cmax)

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	90 days	Collection of adverse events
Incidence of abnormal blood pressure	90 days	Monitor both systolic and diastolic blood pressure
Incidence of abnormal temperature	90 days	Monitor the temperature

Trial Locations

Locations (1)

Phase Ⅰ Clinical Research Center; 🇨🇳 Qingdao, Shandong, China