Bioequivalence of Trametinib 2 mg Tablets vs Reference in Healthy Adults Under Fasting Conditions

This study is a bioequivalence trial designed to evaluate the pharmaceutical equivalence of trametinib 2 mg tablets manufactured by Sun Pharmaceutical Industries Limited compared to the reference product MEKINIST®. The primary objective is to assess the bioequivalence of the test product relative to the reference product in healthy adult subjects under fasting conditions. Establishing bioequivalence is clinically essential to ensure that the generic formulation provides a comparable rate and extent of absorption as the innovator drug.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers of both sexes within the age range categorized by code 3. The clinical context involves various conditions characterized by BRAF mutations, including melanoma, non-small cell lung cancer, low-grade glioma, and anaplastic thyroid cancer.

This is an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study. The investigation compares Trametinib 2 mg tablets manufactured by Sun Pharmaceutical Industries Limited with MEKINIST® 2 mg tablets. The study is conducted in healthy, adult, human subjects under fasting conditions. The research design follows a Phase 2 methodology to assess the equivalence of the two products. The trial is estimated to occur between September 2026 and December 2026.

The efficacy assessment for this phase 2 clinical trial is focused on several indications characterized by BRAF mutations. These include adjuvant treatment for melanoma with V600E or V600K mutations in combination with dabrafenib, as well as unresectable or metastatic solid tumors, non-small cell lung cancer, low-grade glioma, and anaplastic thyroid cancer possessing the V600E mutation.