ANALYTICAL METHOD VALIDATION, PHARMACOKINETICS AND BIOEQUIVALENCE STUDY OF DIMETHYL FUMARATE IN HEALTHY IRANIAN VOLUNTEERS

Objective: Pharmacokinetic evaluation of Dimethyl Fumarate (DMF) in the Iranian population wasn’t studied. So, aim this research is validation analytical method and pharmacokinetic properties bioequivalence generic form drug versus reference product. Methods: 2 single-dose, test, DMF products were orally administered to 24 healthy volunteers. The washout period was 28 d between treatments. Monomethyl fumarate as metabolite analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) validated. Also, parameters calculated for evaluation. Results: validated linear over range 31.25-4000 ng/ml (R2= 0.997). In addition, precise accurate low, medium, high concentrations. results indicated that had similar pharmacokinetics. Further, 90% CI mean ratios test log-transformed area under concentration-time curve 10 h (0.99 1.02) peak concentration (0.98 1.03) within acceptable 0.8 1.25 product could be Conclusion: applied selective, accurate, precise, repeatable analysis monomethyl (MMF) plasma. study showed no significant difference these products. can claimed bioequivalent with