Pharmacokinetics and Bioequivalence of Mycophenolate Sodium Enteric-Coated Tablets Under Fasting and Fed Conditions: A Single-Dose, Open-Label, Four-Period Replicated Crossover Study in Healthy Chinese Male Subjects.

Aim: Enteric-coated mycophenolate sodium (EC-MPS) is an immunosuppressant used to prevent organ rejection in kidney transplant patients. This study assesses the pharmacokinetics and bioequivalence of a generic EC-MPS formulation (180 mg) relative to the branded product (Myfortic Methods: A single-dose, open-label, four-period replicated crossover study with a 7-day washout was conducted in 60 healthy Chinese male subjects under fasting and fed conditions. Eligible subjects were enrolled in two independent trials (fasting and fed conditions) and randomized 1:1 into two treatment sequence groups, with 15 subjects per group. In each group, subjects received a single 180 mg oral dose of the generic or branded product after a 10-hours overnight fast. Plasma concentrations of mycophenolic acid were quantified using a validated LC-MS/MS method. Primary pharmacokinetic parameters (C Results: All subjects completed the study. Bioequivalence was established between the generic and branded formulations under both fasting and fed conditions. In the fasting cohort, 90% CIs for the geometric mean ratios (GMRs) of C Conclusion: The generic EC-MPS demonstrated bioequivalence to the branded product under all tested conditions, supporting its clinical interchangeability. Both formulations were well tolerated in healthy Chinese males. Clinical Trial Registration: http://www.chictr.org.cn/, Registration No: ChiCTR2300075403.