Bioequivalence of Imatinib Mesylate Tablets 400 mg vs Reference Formulation in Healthy Adults Under Fed Conditions

This study is a randomized, two-period, two-sequence, crossover, single-dose bioequivalence trial. The primary objective is to compare the bioavailability of 400 mg imatinib mesylate tablets manufactured by Sun Pharmaceutical Industries Limited with the reference product, Glivec® Coated tablets 400 mg. This evaluation is clinically significant to ensure that the generic formulation demonstrates equivalent pharmacokinetics to the brand-name medication in healthy adult subjects under fed conditions. The scope of this study is 8.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both male and female individuals. Participants are within the pediatric age range. The population includes vulnerable groups. Relevant medical conditions associated with the study context include Philadelphia chromosome-positive acute lymphoblastic leukemia and Philadelphia chromosome-positive chronic myeloid leukemia.

This study is an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study. The investigation compares 400 mg Imatinib Mesylate tablets manufactured by Sun Pharmaceutical Industries Limited with Glivec® 400 mg coated tablets. The clinical assessment is conducted in healthy adult human subjects under fed condition. The research methodology focuses on demonstrating the equivalence of the test product to the reference product. The study design follows a sequence of study visits starting with a screening visit, followed by the treatment periods, and concluding with an end-of-study visit. The estimated duration for recruitment is from May 2026 to June 2026.

The clinical trial is designed to evaluate efficacy in patients diagnosed with Acute Lymphoblastic Leukemia (Ph+ ALL) and Chronic Myeloid Leukemia (Ph+ CML). Due to the absence of specific efficacy parameters, measurement methods, or assessment schedules in the provided source material, no information regarding the evaluation of treatment outcomes is available.