Shandong Chengchuang Blue Ocean Pharmaceutical Technology Co., Ltd.

In accordance with the relevant provisions of bioequivalence tests, Clisborole Ointment (trade name: Sutanming®, specification: 2%), which is licensed by Anacor Pharmaceuticals, Inc., was selected as the reference preparation. The test preparation Clisborole Ointment (specification: 2%) provided by Shandong Chengchuang Blue Ocean Pharmaceutical Technology Co., Ltd. was subjected to a human bioequivalence test for external administration on an empty stomach. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see whether they were within an acceptable range, and the bioequivalence of the two preparations under conditions of external administration on an empty stomach was compared.

This study aimed to investigate the pharmacokinetic characteristics of vonoprazan fumarate tablets (20 mg) developed by Shandong Chengchuang Blue Ocean Pharmaceutical Technology Co., Ltd. after a single oral administration after a meal; vonoprazan fumarate tablets (Walker®, 20 mg) produced by Takeda Pharmaceutical Company Limited, Hikari Plant was used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

This study aimed to investigate the pharmacokinetic characteristics of a single fasting and postprandial oral dose of vonoprazan fumarate tablets (20 mg) developed by Shandong Chengchuang Blue Ocean Pharmaceutical Technology Co., Ltd.; using vonoprazan fumarate tablets (Walker®, 20 mg) produced by Takeda Pharmaceutical Company Limited, Hikari Plant as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.