Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Bioequivalence of Ezetimibe Tablets in Healthy Subjects: A Single-dose and Two-period Crossover Study

Conditions
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Therapeutic Equivalency

Intervention / Treatment
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* Drug: ezetimibe tablets
* Drug: ezetimibe tablets(Ezetrol ®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ezetimibe Tablets<br>ezetimibe tablets test formulation at a single dose of 10 mg | Drug: ezetimibe tablets<br>* The subjects randomly received single oral administration of ezetimibe tablets 10 mg.<br>|
| Active Comparator: ezetimibe tablets(Ezetrol ®)<br>ezetimibe tablets reference formulation at a single dose of 10 mg | Drug: ezetimibe tablets(Ezetrol ®)<br>* The subjects randomly received single oral administration of ezetimibe tablets 10 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Collection of adverse events | 90 days | 
| Incidence of abnormal blood pressure | Monitor both systolic and diastolic blood pressure | 90 days | 
| Incidence of abnormal temperature | Monitor the temperature | 90 days |