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More info
You can access this
clinical trial
if you have
Hypercholesterolaemia
and you are
between 18 and 45
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: 10mg Ezetimibe
  • Drug: 10 mg Ezetimibe - wash out period

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01597700. The sponsor of the trial is GlaxoSmithKline and it is looking for 52 volunteers for the current phase.
Official trial 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