Pharmacokinetic And Bioequivalent Study Of Mefenamic Acid Dispersible Tablets In The Healthy Volunteers

To be on the market, clinical study is required for every new drug after preclinical study. Different requirements are set for new drugs of different registered type. According to the management methods of drug registration issued from State Food and Drug Administration (SFDA), mefenamic acid belongs to the type five new drugs, namely, renewing the formulation while keeping the original administration route. Oral preparations of this type new drug are demanded to perform bioequivalence evaluation in clinic study. That means no statistic significance exists on the speed and extent of absorption between the new and conventional formulations under same dosage and same experimental system. Bioequivalent study provides a biologic standard for the drug formulation and direct proof for the clinic effect ion.AIM: This study aims to establish an High Performance Liquid chromatography (HPLC) method to monitor the concentration of mefenamic acid in human serum samples, to clarify its pharmacokinetics profiles such as absorption, disposition, metabolism and elimination in health body, and evaluate the bioequivalence of mefenamic acid dispersible tablets and conventional tablets to provide scientific ground for safe and reasonable...