Shandong Province Renhetang Pharmaceutical Co. Ltd.

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.

Primary objective: To evaluate the bioequivalence of the test preparation of ketotifen fumarate tablets produced by Renhetang Pharmaceutical Co., Ltd. and the reference preparation of ketotifen fumarate tablets (trade name: Zaditen®) produced by Novartis Pharma Schweiz AG after a single oral administration in healthy subjects in the fasting and postprandial states. Secondary objective: To observe the safety of the test preparation of ketotifen fumarate tablets and the reference preparation in healthy subjects after oral administration.