Suzhou Gaomai Pharmaceutical Co., Ltd.

This study aims to study the pharmacokinetic characteristics of a single fasting application of levocaine cream (1 g: lidocaine 25 mg, prilocaine 25 mg) developed by Suzhou Gaomai Pharmaceutical Co., Ltd. and produced by Yaoyuan Biotechnology (Qidong) Co., Ltd. to healthy study participants; using the levocaine cream (Emla®, 1 g: lidocaine 25 mg, prilocaine 25 mg) licensed by Aspen Pharma Trading Limited as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two doses in humans. Secondary objective: To observe the safety of the test preparation and the reference preparation after a single application in healthy study participants.

Main objective: This study aims to study the pharmacokinetic characteristics of a single fasting application of a generic diclofenac diethylamine emulsion [1% (20 g: 0.2 g, calculated as diclofenac sodium)] produced by Suzhou Gaomai Pharmaceutical Co., Ltd. in healthy study participants; using diclofenac diethylamine emulsion [Voltaren®, 1% (20 g: 0.2 g, calculated as diclofenac sodium)] produced by GSK Consumer Healthcare S.A. 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.

The purpose of this study was to study the pharmacokinetic characteristics of a single topical application of crisaborole ointment (2% (30 g: 0.6 g)) developed by Suzhou Gaomai Pharmaceutical Co., Ltd. and produced by Yaoyuan Biotechnology (Qidong) Co., Ltd. to healthy subjects; using the certified crisaborole ointment (Sultanamine®, 2% (30 g: 0.6 g)) of Anacor Pharmaceuticals, Inc. as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the human bioequivalence of the two preparations was evaluated.