Bioequivalence Study of Ezetimibe Tablets Under Fed Conditions in Healthy Subjects

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pharmacokinetics, Safety

Intervention / Treatment
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* Behavioral: Reference preparation-Reference preparation-Test Preparation
* Behavioral: Reference preparation-Test Preparation-Reference preparation
* Behavioral: Test Preparation-Reference preparation-Reference preparation


Participation Criteria
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Eligibility Criteria
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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.

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: Test preparation<br>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-Reference preparation<br>* Under fed conditions, subjects randomly divided into RTR group were given one tablet of test preparation first, and then one tablet of reference preparation after cleaning period, and then one tablet of reference preparation after cleaning period.<br>|
| Active Comparator: Reference preparation<br>Ezetimibe Tablets Ezetrol ®; Specification: 10mg, packaging specification: 10 pieces / plate, 1 plate / box; Licensee: MSD Pharma (Singapore) PTE. Ltd | Behavioral: Reference preparation-Reference preparation-Test Preparation<br>* Under fed conditions, subjects randomly divided into RRT group were given one tablet of reference preparation first, and then one tablet of reference preparation after cleaning period, and then one tablet of test preparation after cleaning period.<br>Behavioral: Reference preparation-Test Preparation-Reference preparation<br>* Under fed conditions, subjects randomly divided into RTR group were given one tablet of reference preparation first, and then one tablet of test preparation after cleaning period, and then one tablet of reference preparation after cleaning period.<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) | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ezetimibe