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More info
You can access this
clinical trial
if you have
Purpura, Thrombocytopenic, Idiopathic, Acute Idiopathic Thrombocytopenic Purpura or Chronic Thrombocytopenia
and you are
between 18 and 55
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

This will be a randomized, open-label, four-group, two-period, replicate design study to evaluate the effect of food on within and between subject variability in second generation formulation 20-mg tablet strengths, Lots P01008ZZA and P01009ZZA, administered as single doses of 40mg to 84 healthy male and female subjects. The study is powered to detect both a reduction in either the within or between subject variability (coefficient of variation [CV]%) of approximately 35%.

Provided treatments

  • Drug: E5501 40 mg 2 x 20-mg tablets, orally, fasted
  • Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food
  • Drug: E5501 40mg 2 x 20-mg tablets, orally, fasted
  • Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food

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: NCT01327872. The sponsor of the trial is Eisai Inc. and it is looking for 84 volunteers for the current phase.
Official trial title:
A Randomized, Open-Label, 4-Group, 2-Period Replicate Design Study to Evaluate Within- and Between-Subject Variability in Exposure of Two Lots of E5501 20 mg Tablets, Administered as Single Doses of 40 mg, in the Fasted and Fed Conditions to Healthy Subjects