Unihealth Biopharmaceutical Limited

Primary objective: According to the relevant provisions of bioequivalence tests, brepirazole tablets (RXULTI®, specification: 2 mg) of Otsuka Pharmaceutical Netherlands B.V. were selected as the reference preparation. The test preparation brepirazole orodispersible film (specification: 2 mg) provided by Shenzhen Yujian Biopharmaceutical Co., Ltd. was subjected to human bioequivalence tests under fasting and postprandial administration conditions, and the pharmacokinetic characteristics of the test preparation and the reference preparation were compared to evaluate the bioequivalence of the two preparations under fasting or postprandial administration conditions. Secondary objectives: To evaluate the palatability (including taste, odor, aftertaste), grittiness, adhesion and irritation of brepirazole orodispersible film; to evaluate the safety of single-dose oral administration of the test preparation brepirazole orodispersible film (specification: 2 mg) and the reference preparation brepirazole tablets (specification: 2 mg) in healthy Chinese subjects.

The test preparation was levocaine cream produced by Guangdong China Resources Shunfeng Pharmaceutical Co., Ltd. and commissioned by Shenzhen Yujian Biotechnology Co., Ltd., and the reference preparation was levocaine cream (trade name: EMLA) produced by Recipharm Karlskoga AB. The test preparation and the reference preparation were applied to healthy adult subjects in the fasting state, and the concentrations of lidocaine and prilocaine in plasma were determined. The absorption rate and extent of the test preparation and the reference preparation were studied, and the bioequivalence of the two preparations under fasting conditions was evaluated.