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| Name | Class |
|---|---|
| Changzhou Pharmaceutical Factory Co., Ltd | UNKNOWN |
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The fasting 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 fasting 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 |
|---|---|---|---|---|
| Test Preparation-Reference preparation | Behavioral | Under fasting conditions, subjects randomly divided into TR group were given one tablet of test preparation first, and then one tablet of reference 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of abnormal temperature | Monitor the temperature | 33 days |
| Incidence of abnormal pulse | Monitor the pulse | 33 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Li, Doctor | Contact | 15065327781 | dove1202@sina.com | |
| Yu Cao, Doctor | Contact | 18661809090 | caoyu1767@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Cao, Doctor | National Medical Products Administration | Principal Investigator |
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The technical achievements (including but not limited to patent right and thesis publishing right) involved in this trial, clinical research materials and achievements are owned by Zhejiang onlycom Pharmaceutical Co., Ltd. With the written consent of Zhejiang onlycom Pharmaceutical Co., Ltd., all partners have the right to publish academic papers, and the Affiliated Hospital of Qingdao University, a clinical research institution, has the right to exchange research results in academic conferences or journals.
The data have been available on May 22, 2022. The duration has not been determined.
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| Reference preparation-Test Preparation | Behavioral | Under fasting conditions, subjects randomly divided into RT group were given one tablet of reference preparation first, and then one tablet of test preparation after cleaning period. |
|
| Incidence of abnormal electrocardiogram waveform | Electrocardiogram inspection | 33 days |