An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Imatinib Mesylate Tablets 400 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Glivec® (Imatinib mesylate) Coated tablets 400 mg, Produced by Novartis Pharma Produktions GmbH, Wehr, Germany or Novartis Pharmaceutical Manufacturing LLC, Ljubljana; Imported and Registered by Novartis Biosciences SA, Prof. Vicente Rao Avenue, 90, Sao Paulo – SP, CNPJ: 56.994.
IMATI-10-25
Quick answer
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Imatinib Mesylate Tablets 400 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Glivec® (Imatinib mesylate) Coated tablets 400 mg, Produced by Novartis Pharma Produktions GmbH, Wehr, Germany or Novartis Pharmaceutical Manufacturing LLC, Ljubljana; Imported and Registered by Novartis Biosciences SA, Prof. Vicente Rao Avenue, 90, Sao Paulo – SP, CNPJ: 56.994. for Acute Lymphoblastic Leukemia (Ph+ ALL), (Ph+) Chronic Myeloid Leukemia is a Phase 1 program (other) at Pharma Mar S.A. with 1 ClinicalTrials.gov record(s).
Program details
- Company
- Pharma Mar S.A.
- Indication
- Acute Lymphoblastic Leukemia (Ph+ ALL), (Ph+) Chronic Myeloid Leukemia
- Phase
- Phase 1
- Modality
- other
- Status
- active