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This study was conducted to assess the bioequivalence of the ezetimibe tablet to Ezetrol ® in healthy Chinese volunteers and estimate the pharmacokinetic profiles of ezetimibe tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ezetimibe tablet | Experimental | ezetimibe tablet test formulation at a single dose of 10 mg |
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| ezetimibe tablet(Ezetrol ®) | Active Comparator | ezetimibe tablet reference formulation at a single dose of 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe tablet | Drug | The subjects randomly received single oral administration of ezetimibe tablet 10 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax) | Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax) | 80 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 80 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center | Qingdao | Shandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36737825 | Derived | Sun F, Liu Y, Li T, Lin P, Jiang X, Li X, Wang C, Gao X, Ma Y, Fu Y, Cao Y. Pharmacokinetics and bioequivalence of Ezetimibe tablet versus Ezetrol(R):an open-label, randomized, two-sequence crossover study in healthy Chinese subjects. BMC Pharmacol Toxicol. 2023 Feb 3;24(1):7. doi: 10.1186/s40360-023-00649-y. |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 tablet(Ezetrol ®) | Drug | The subjects randomly received single oral administration of ezetimibe tablet (Ezetrol ®) 10 mg. |
|