A multicenter, open label, randomized, balanced, two treatment, two period, two sequence, two way crossover, multiple dose, comparative oral bioavailability study of Imatinib mesylate tablets 400mg of Onco Therapies Limited (a subsidiary of Strides Arcolab Ltd.), India with Gleevec (Imatinib Mesylate) Tablets 400mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey in adult human patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor under fed steady-state condition

Trial Profile

A multicenter, open label, randomized, balanced, two treatment, two period, two sequence, two way crossover, multiple dose, comparative oral bioavailability study of Imatinib mesylate tablets 400mg of Onco Therapies Limited (a subsidiary of Strides Arcolab Ltd.), India with Gleevec (Imatinib Mesylate) Tablets 400mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey in adult human patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor under fed steady-state condition

Completed
Phase of Trial: Phase I

Latest Information Update: 31 Aug 2016

At a glance

  • Drugs Imatinib (Primary)
  • Indications Gastrointestinal stromal tumours; Myeloid leukaemia
  • Focus Pharmacokinetics
  • Most Recent Events

    • 06 May 2013 Status changed from recruiting to completed as reported by Clinical Trials Registry - India.
    • 12 Mar 2013 New trial record
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