Shaanxi Dongke Pharmaceutical Co. Ltd.

Primary objective: To evaluate the bioequivalence of the test preparation and the reference preparation (lidocaine gel patch developed by Teikoku Seiyaku Co., Ltd.) under topical conditions in healthy Chinese subjects, using the in vivo pharmacokinetic parameters (Cmax and AUC) of lidocaine as bioequivalence evaluation indicators. Secondary objective: To observe the safety of the test preparation and the reference preparation under topical conditions in healthy Chinese subjects, and to evaluate the adhesion and irritation of the test preparation and the reference preparation.

Using Chinese healthy subjects as the test subjects, a self-crossover design was used to determine the time course of montelukast plasma concentration in healthy subjects after administration of montelukast sodium granules developed by Shaanxi Dongke Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Using montelukast sodium granules [trade name: Singerling®] certified by Merck Sharp & DohmeCorp and produced by Patheon Manufacturing Services LLC as a reference, the relative bioavailability of the test preparation was investigated, the bioequivalence between the preparations was evaluated, and the safety of montelukast sodium granules in Chinese healthy subjects was observed.