Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.
Condition: Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This is a randomized, balanced, open label, crossover, two period, two treatment, two
      sequence, single dose bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet
      manufactured by Laboratorios Phoenix, Argentina with a reference comparator Zetia® ezetimibe
      10 mg tablet of Merck/Schering-Plough Pharmaceuticals, USA. The CRO Clinigene International
      Ltd, Bangalore, India will conduct the study. Fifty two healthy male adult subjects who have
      satisfied the inclusion and exclusion criteria and given their written informed consent will
      be entered into the study. They 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; meals and water ad libitum will be allowed. Between 14 and
      21 days later, subjects will return to the clinic and follow the same procedure to receive
      the opposite tablet and the clinical process repeated. Subjects will be continuously safety
      monitored while in the trial clinic and at ambulatory visits with regular measurements of
      vital signs and questioned for adverse events in accordance with the trial clinic SOPs. Drug
      concentrations will be analysed and these results compared in accordance with the study
      protocol to ascertain bioequivalence by applying statistical methods to the pharmacokinetic
      data; this information and all safety data will be formally reported to GSK.
    

Intervention name(s): 10mg Ezetimibe; 10 mg Ezetimibe - wash out period
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet taken by mouth; 1 tablet taken by mouth received after wash out period
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other