Harbin Medisan Pharmaceutical Co., Ltd.

Main purpose: To use healthy subjects as test subjects, adopt an open, randomized, two-period, double-crossover design, to investigate the in vivo time course of brepirazole after a single oral administration of brepirazole tablets (test preparation, specification: 2mg) produced by Lanxiha Sanlian Pharmaceutical Co., Ltd. (certified by Harbin Sanlian Pharmaceutical Co., Ltd.) and brepirazole tablets (reference preparation, Rexulti®, specification: 2mg) produced by Otsuka Pharmaceutical Co., Ltd. on an empty stomach and after a meal, estimate their relevant pharmacokinetic parameters and relative bioavailability, evaluate their bioequivalence in the fasting and after-meal state, and provide a basis for the production registration application of the test preparation. Secondary purpose: To evaluate the safety of the test preparation and reference preparation (trade name: Rexulti®) of brepirazole tablets in healthy subjects.

Main research purpose: According to the relevant provisions of bioequivalence test, nimodipine tablets (trade name: Nimotop®, specification: 30mg) licensed by Bayer Healthcare Co., Ltd. were selected as the reference preparation, and the test preparation nimodipine tablets (specification: 30mg) licensed by Harbin Sanlian Pharmaceutical Co., Ltd. and produced by Lanxiha Sanlian Pharmaceutical Co., Ltd. were tested for fasting and postprandial administration in humans, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation nimodipine tablets (specification: 30mg) and the reference preparation nimodipine tablets (trade name: Nimotop®, specification: 30mg) by healthy volunteers.

Main purpose: With healthy subjects as the test subjects, an open, randomized, two-period, double-crossover design was adopted to investigate the in vivo time course of roxadustat after a single oral administration of roxadustat capsules (test preparation, specification: 50 mg) produced by Lanxiha Sanlian Pharmaceutical Co., Ltd. (certified by Harbin Sanlian Pharmaceutical Co., Ltd.) and roxadustat capsules (reference preparation, Aerzhuo®, specification: 50 mg) produced by FibroGen (China) Pharmaceutical Technology Development Co., Ltd. on an empty stomach and after a meal, to estimate their relevant pharmacokinetic parameters and relative bioavailability, to evaluate their bioequivalence in the fasting and after-meal state, and to provide a basis for the production registration application of the test preparation. Secondary purpose: To evaluate the safety of the test preparation and reference preparation of roxadustat capsules (trade name: Aerzhuo®) in healthy subjects.