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The intent of this study is to demonstrate that single doses of the Final Market Image (FMI) ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are bioequivalent to the same doses of ezetimibe (ZETIA®) and atorvastatin (LIPITOR®) that are coadministered as individual tablets in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe 10mg and Atorvastatin 10mg | Active Comparator | Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered |
|
| 10mg Ezetimibe/10mg Atorvastatin | Experimental | 10mg Ezetimibe/10mg atorvastatin combination tablet |
|
| Ezetimibe 10mg and Atorvastatin 80mg | Active Comparator | Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered |
|
| 10mg Ezetimibe/80mg Atorvastatin | Experimental | Ezetimibe/atorvastatin 10mg/80mg combination tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe | Drug | Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatin | Hour 0 to Hour 48 | |
| Maximum plasma concentration (Cmax) of atorvastatin | Hour 0 to Hour 48 | |
| Area under the concentration time-curves from time zero to the time of last measured concentration (AUC0-last) of unconjugated ezetimibe (EZ) | Hour 0 to Hour 96 | |
| Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ) | Hour 0 to Hour 96 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michael Seiberling, MD | Covance Clinical Research Unit AG, Lettenweg 118, CH-4123 Allschwil (Basel), Switzerland | Principal Investigator |
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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 |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Ezetimibe/atorvastatin 10mg/10mg FDC | Drug | Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours). |
|
|
| Atorvastatin 10mg | Drug | Atorvastatin 10mg given orally after an overnight fast (at least 10 hours). |
|
|
| Atorvastatin 80mg | Drug | Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours). |
|
|
| Ezetimibe/atorvastatin 10mg/80mg FDC | Drug | Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours). |
|
|
| D011758 |
| Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |