Hubei Keyi Pharmaceutical Co., Ltd.

Main study objectives Using acyclovir tablets (specification: 0.2g) developed and produced by Hubei Keyi Pharmaceutical Co., Ltd. as the test preparation and acyclovir tablets (trade name: Zovirax®, specification: 0.2g) certified by Glaxo Smithkline K.K. as the reference preparation, the pharmacokinetic parameters of the two preparations in healthy subjects were compared, and the bioequivalence of the two preparations in the fasting and postprandial states was evaluated. Secondary study objectives Observe the safety of the test preparation acyclovir tablets and the reference preparation acyclovir tablets (Zovirax®) in healthy subjects.

Valacyclovir hydrochloride tablets (specification: 0.5g) provided by Hubei Keyi Pharmaceutical Co., Ltd. were used as the test preparation, and valacyclovir hydrochloride tablets (trade name: Valtrex®, specification: 0.5g) of The Wellcome Foundation Limited were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic parameters of the two preparations in healthy humans were compared to investigate the human bioequivalence of the two preparations.

Chinese healthy subjects were used as test subjects. A self-crossover design was used to determine the time course of plasma crisaborole concentrations in healthy subjects after administration of the test formulation of crisaborole ointment [Specification: 2% (30 g: 0.6 g)], and the corresponding pharmacokinetic parameters were estimated. The crisaborole ointment [trade name: Staquis®, specification: 2%] licensed by Anacor Pharmaceuticals, Inc. and produced by Pharmacia and Upjohn Company LLC was used as the reference preparation to evaluate the bioequivalence between the preparations and observe the safety of crisaborole ointment in Chinese healthy subjects.