An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Ponatinib Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Iclusig (Ponatinib hydrochloride) tablets 15 mg, Produced by: Patheon Inc. Mississauga, Canada or Takeda Ireland Limited Bray, Ireland, Imported and registered by: Pint Pharma Medical-Hospital and Pharmaceutical Products Ltd. Nelson Pontes Street, 125, Block 03, Jardim Margar
Phase 4 – monitoring after market approval
Conditions:
chronic myeloid leukemia
Philadelphia chromosome-positive acute lymphoblastic leukemia
Sponsor: Sun Pharmaceutical Industries Limited
trial.available_in:
БГ
Overview
Trial status: Authorised
Who can participate
Age group: 18-64 years
Gender: Male
Target enrollment: 56 participants
БГ