Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.
Status:
Completed
Trial end date:
2012-01-30
Target enrollment:
Participant gender:
Summary
Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by
Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of
Merck/Schering-Plough Pharmaceuticals. The CRO Clinigene Bangalore, will conduct the study.
Fifty two healthy adult subjects who have satisfied the inclusion and exclusion criteria and
given their informed consent will be entered into the study. They will be fasted and receive
one tablet by mouth in accordance with a randomisation list and blood samples will be taken
at specified intervals over the ensuing 3 days. Between 14 and 21 days later, subjects will
receive the opposite tablet and the clinical process repeated. Subjects will be continuously
monitored while in the trial clinic and at ambulatory visits with regular measurements of
vital signs and questioned for adverse events. Drug concentrations will be analysed and these
results compared to ascertain bioequivalence by applying statistical methods to the
pharmacokinetic data; this information and all safety data will be formally reported.