ezetimibe
DrugEzetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).
Other names: Zetia
NCT Number: NCT01236430
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).
Other names: Zetia
Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours).
Other names: SCH 900068
Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).
Other names: Lipitor
Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).
Other names: Lipitor
Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours).
Other names: SCH 900068
Time frame: Hour 0 to Hour 48
Time frame: Hour 0 to Hour 48
Time frame: Hour 0 to Hour 96
Time frame: Hour 0 to Hour 96
Organon and Co
Industry
A Study to Evaluate the Definitive Bioequivalence of SCH 900068 With Marketed Products (Protocol No. P07551)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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