Zhejiang Shangyao Jiuzhou Biopharmaceutical Co., Ltd.

According to the relevant provisions of bioequivalence tests, Anacor Pharmaceuticals, Inc. was selected as the reference preparation for the single fasting topical administration of crisaborole ointment (trade name: Sutanming®, specification: 2%), which was produced by Ruihua (Zhongshan) Pharmaceutical Co., Ltd. and provided by Zhejiang SPH Jiuzhou Biopharmaceutical Co., Ltd., to conduct a preliminary human bioequivalence study to evaluate the pharmacokinetic characteristics of the two preparations and provide a reference for the formal test design. At the same time, the safety of the single topical application of the test preparation and the reference preparation in healthy volunteers was observed.

In accordance with the relevant provisions of bioequivalence tests, oxcarbazepine oral suspension (trade name: Trileptin®, specification: 60 mg/mL (packaging specification 100 mL)) licensed by Novartis Pharma Schweiz AG was selected as the reference preparation. The test preparation oxcarbazepine oral suspension (specification: 60 mg/mL) licensed by Zhejiang SPH Jiuzhou Biopharmaceutical Co., Ltd. and produced by Shanghai Zhonghua Pharmaceutical Co., Ltd. was subjected to a preliminary human bioequivalence study on fasting and postprandial administration to evaluate the pharmacokinetic characteristics of the two preparations and provide a reference for the formal trial design.

After a single oral dose of the test and reference formulations of dapagliflozin tablets was administered to healthy adult subjects in the fasting and fed states, pharmacokinetic parameters were used as endpoint evaluation indicators to evaluate whether dapagliflozin tablets (specification: 10 mg) provided by Zhejiang Shanghai Pharmaceuticals Jiuzhou Biopharmaceutical Co., Ltd. were bioequivalent to dapagliflozin tablets produced by AstraZeneca Pharmaceuticals LP (licensed trader: AstraZeneca AB, trade name: Andatang®, specification: 10 mg).