Comparative Bioequivalence Evaluation of Two Formulations of Metaxalone 800 mg Tablets Under Fed Conditions in Healthy Adult Volunteers A Randomized, Open-Label, Three-Way Crossover Study
Dr. Bhanu Prakash, Hyderabad.
DOI: https://doi.org/10.63712/bpsrj-v2i3p002
ABSTRACT:
Background: Metaxalone is a centrally acting skeletal muscle relaxant widely used for the management of musculoskeletal pain and discomfort. Demonstration of bioequivalence between generic and innovator formulations is essential for ensuring therapeutic interchangeability. Objective: To compare the pharmacokinetic characteristics and bioequivalence of two test formulations of Metaxalone 800 mg tablets manufactured by RA Chem Pharma Ltd. with the reference product, Skelaxin® 800 mg tablets, under fed conditions in healthy adult volunteers.