Mudanjiang Hengyuan Pharmaceutical Co., Ltd.

The primary objective was to observe the time course of plasma drug concentrations of the test formulation, mesalamine suppositories (1g, manufactured by Zhejiang Thermo Pharmaceutical Co., Ltd.), in healthy volunteers in the fasting state and estimate the corresponding pharmacokinetic parameters. A human bioequivalence study was conducted using mesalamine suppositories (PENTASA®, 1g, licensee: Ferring GmbH) as the reference formulation to provide a reference for drug registration and clinical application. The secondary objective was to observe the safety of the test and reference formulations in subjects in the fasting state.

Main objective: To evaluate the relative bioavailability and bioequivalence of mesalazine enteric-coated tablets produced by Mudanjiang Hengyuan Pharmaceutical Co., Ltd. as the test preparation and mesalazine enteric-coated tablets produced by Dr. Falk Pharma GmbH as the reference preparation.

Montelukast Sodium Chewable Tablets licensed by Mudanjiang Hengyuan Pharmaceutical Co., Ltd. were used as the test preparation, and Montelukast Sodium Chewable Tablets of N.V. Organon were used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.