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: 56.994.502/0001-30, Brazilian Industry, in healthy adult, human subjects under fed condition.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524935-38-00

Enrollment

Registered

2026-05-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia (Ph+ ALL), (Ph+) Chronic Myeloid Leukemia

None listed

Sex/Gender

All

Age

18 Years to 64 Years

None listed

Source: EU CTIS · Data processed: May 6, 2026