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More info
You can access this
clinical trial
if you have
Comparative Bioavailability of Clopidogrel Tablets
and you are
between 18 and 40
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

Background: Clopidogrel, a potent inhibitor of adenosine diphosphate-induced platelet activation, is widely used to prevent and reduce the risk of thrombotic events. Objective: the aim of the present study is to evaluate the bioequivalence of two oral formulations of 75 mg clopidogrel tablets. Method: The study is an open, randomized, single-dose, two-period crossover trial conducted on 32 healthy Mexican volunteers in a fasted state. A single oral dose of the test or reference drug will be followed by a 7 day washout period, after which subjects will receive the alternative formulation. Blood samples were collected up to 24 h after dosing. In order to determine bioequivalence, the plasma concentrations of clopidogrel carboxylic acid metabolite was determined using high-performance liquid chromatography-tandem mass spectrometry area under the plasma concentration time curve from zero to the last quantifiable level (AUC0-t), area under the plasma concentration time curve extrapolated to infinity (AUC0-∞), maximum plasma concentration (Cmax), the plasma elimination half-life (Tmax) and plasma half-life (T1/2) were calculated for both formulations.

Provided treatments

  • Drug: Clopidogrel bisulfate
  • Drug: Clopidogrel

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: NCT01447563. The sponsor of the trial is Hospital Universitario Dr. Jose E. Gonzalez and it is looking for 32 volunteers for the current phase.
Official trial title:
Bioavailability of Two Oral Formulations of Clopidogrel: A Randomized, Open Label, Single Dose, Two-Period, Crossover Comparison in Healthy Mexican Volunteers