Shandong Province Renhetang Pharmaceutical Co. Ltd.

The sodium valproate tablets (specification: 0.2 g) developed by Renhetang Pharmaceutical Co., Ltd. were used as the test preparation, and the sodium valproate tablets (specification: 0.2 g, Depakene®) certified by Kyowa Hakko Kirn Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations were investigated in the fasting and postprandial states, and the bioequivalence of the two preparations was evaluated. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Main study objectives A randomized, open, two-treatment, two-period crossover design was used to evaluate the oral bioequivalence of clozapine tablets (specification: 25 mg) produced by Renhetang Pharmaceutical Co., Ltd. and clozapine tablets (specification: 25 mg, trade name: Clozaril®) certified by HERITAGE LIFE SCIENCES BARBADOS INC in Chinese schizophrenia subjects, and to provide evidence for the consistency of clinical efficacy between clozapine tablets produced by Renhetang Pharmaceutical Co., Ltd. and clozapine tablets certified by HERITAGE LIFE SCIENCES BARBADOS INC. Secondary study objectives Observe the safety of the test preparation clozapine tablets and the reference preparation clozapine tablets in subjects.

This study investigated the pharmacokinetic characteristics of a single oral administration of isosorbide mononitrate tablets produced by Renhetang Pharmaceutical Co., Ltd. (test preparation, specification: 20 mg) or isosorbide mononitrate tablets certified by LANNETT CO INC (reference preparation, specification: 20 mg) under fasting and postprandial conditions, evaluated the bioequivalence between the two preparations, and provided a basis for the consistency evaluation of the test preparation.