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Clinical trial

A Randomized, Open Label, Two-Treatment, Multiple Dose, Steady State, Two-period, Cross-over, Multi-Centre Comparative Bioequivalence Study of Imatinib Mesylate Tablet 400 mg of Amneal Pharmaceuticals, USA With GLEEVEC® (Imatinib Mesylate) Tablets 400 mg Distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions

NCT02103322 is registered in ClinicalTrials.gov with Amneal Pharmaceuticals, LLC as lead sponsor.

NCT NCT02103322
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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Open Label, Two-Treatment, Multiple Dose, Steady State, Two-period, Cross-over, Multi-Centre Comparative Bioequivalence Study of Imatinib Mesylate Tablet 400 mg of Amneal Pharmaceuticals, USA With GLEEVEC® (Imatinib Mesylate) Tablets 400 mg Distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions
Lead sponsor
Amneal Pharmaceuticals, LLC
Phase
Phase 2/3
Overall status
Completed
Start date
February 28, 2014
Completion date
June 30, 2014
Enrollment
48 (actual)
Sites
5

Conditions

As the registry lists them; a condition with its own page is linked.

chronic myeloid leukemia, gastrointestinal stromal tumor