A Randomized, Open-Label, Two-Period, Two-Sequence, Crossover Bioequivalence Study of Ponatinib 15 mg in Healthy Adult Subjects under Fasting Conditions

The primary objective of this study is to evaluate the bioequivalence of 15 mg ponatinib tablets manufactured by Sun Pharmaceutical Industries Limited compared to the reference product, Iclusig. Establishing bioequivalence is essential to ensure that the test product provides comparable pharmacokinetic performance to the brand-name medication in healthy adult subjects under fasting conditions.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers. The participants are male and within the age range of 19 to 44 years. No data were provided regarding specific medical conditions, lifestyle considerations, or inclusion and exclusion criteria.

This bioequivalence study is designed as an open-label, randomized, two-period, two-sequence, crossover trial. The investigation involves a single-dose administration of 15 mg ponatinib tablets, comparing a test product manufactured by Sun Pharmaceutical Industries Limited with the reference drug Iclusig. The study will be conducted in healthy adult human subjects under fasting conditions. The research methodology follows a two-treatment design to evaluate the equivalence of the products. The clinical trial period is estimated to occur between April 2026 and July 2026. Participant involvement includes a screening visit to assess eligibility, followed by scheduled study visits to monitor the administration and effects of the medication, and an end-of-study visit. Early termination from the study may occur based on protocol-defined conditions.

The efficacy assessment in this clinical trial involves the evaluation of participants diagnosed with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.