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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ezetimibe Tablets | Experimental | ezetimibe tablets test formulation at a single dose of 10 mg |
|
| ezetimibe tablets(Ezetrol ®) | Active Comparator | ezetimibe tablets reference formulation at a single dose of 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe tablets | Drug | The subjects randomly received single oral administration of ezetimibe tablets 10 mg. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yu Cao, doctor | Contact | 86 18661809090 | caoyu1767@126.com |
| Name | Affiliation | Role |
|---|---|---|
| yu Cao, doctor | the study director of phase I clinical research center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase Ⅰ Clinical Research Center | Recruiting | Qingdao | Shandong | 266003 | China |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| ezetimibe tablets(Ezetrol ®) | Drug | The subjects randomly received single oral administration of ezetimibe tablets 10 mg. |
|
| 90 days |
| Incidence of abnormal temperature | Monitor the temperature | 90 days |