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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test preparation | Experimental | Ezetimibe tablets: specification: 10mg; Package specification: 7 pieces / plate, 1 plate / box; Produced and provided by Changzhou Pharmaceutical Factory Co., Ltd. |
|
| Reference preparation | Active Comparator | Ezetimibe Tablets Ezetrol ®; Specification: 10mg, packaging specification: 10 pieces / plate, 1 plate / box; Licensee: MSD Pharma (Singapore) PTE. Ltd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference preparation-Reference preparation-Test Preparation | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
• Healthy male or female aged 18 and above.
Exclusion Criteria:
• Being allergy to the study medications, smoking, alcohol abuse.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I clinical research center | Qingdao | Shandong | 266003 | China |
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|
| Reference preparation-Test Preparation-Reference preparation | Behavioral | 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. |
|
| Test Preparation-Reference preparation-Reference preparation | Behavioral | 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. |
|
| 33 days |
| Incidence of abnormal pulse | Monitor the pulse | 33 days |
| Incidence of abnormal electrocardiogram waveform | Electrocardiogram inspection | 33 days |