Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.
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|ClinicalTrials.gov Identifier: NCT01597700|
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolaemia||Drug: 10mg Ezetimibe Drug: 10 mg Ezetimibe - wash out period||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A RANDOMIZED, BALANCED, OPEN LABEL, CROSSOVER, TWO PERIOD, TWO TREATMENT, TWO SEQUENCE, SINGLE DOSE, BIOEQUIVALENCE STUDY OF ACOTRAL® EZETIMIBE 10 MG TABLETS CONTAINING EZETIMIBE MANUFACTURED BY LABORATORIOS PHOENIX S.A.I.C.F, ARGENTINA AND ZETIA® EZETIMIBE 10 MG TABLETS OF MERCK/SCHERING - PLOUGH PHARMACEUTICALS, USA IN HEALTHY ADULT HUMAN MALE SUBJECTS UNDER FASTING CONDITION|
|Actual Study Start Date :||January 13, 2012|
|Actual Primary Completion Date :||January 30, 2012|
|Actual Study Completion Date :||January 30, 2012|
Experimental: Acotral® ezetimibe 10mg
Subjects will be fasted overnight and receive one tablet by mouth in accordance with a randomisation list and venous blood samples will be taken at specified intervals over the ensuing 3 day.
Drug: 10mg Ezetimibe
1 tablet taken by mouth
Active Comparator: Zetia® ezetimibe 10mg
Subjects will be fasted overnight and receive one tablet by mouth in accordance with a randomisation list and venous blood samples will be taken at specified intervals over the ensuing 3 days.
Drug: 10 mg Ezetimibe - wash out period
1 tablet taken by mouth received after wash out period
- Changes from baseline in plasma ezetimibe concentrations in time after dosing [ Time Frame: At 0 time and up to 72 hours after last dose ]Liquid chromatography and mass spectrometry
- Number of participants with adverse events [ Time Frame: At 0 time and up to 72 hours after last dose ]Safety monitoring
- Number of participants with changes in haematology and/or chemistry [ Time Frame: 21 to 0 days before first dose and 3 days after last dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597700
|GSK Investigational Site|
|Electronics City, Bengalore, India, 560100|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|