Shenzhen Taili Biomedicine Co., Ltd.

The primary study objective was to investigate the pharmacokinetic characteristics of a single application of the test formulation, lidocaine cream (30g, lidocaine 750mg, prilocaine 750mg) provided by Shenzhen Yujian Biopharmaceutical Co., Ltd., and the reference formulation, lidocaine cream (1g, reference formulation R, EMLA®, lidocaine 25mg, prilocaine 25mg) licensed by Aspen Pharma Trading Limited, in healthy volunteers under the fasting state, and to evaluate the bioequivalence of the two formulations. The secondary study objective was to investigate the safety of a single application of the test formulation, lidocaine cream (30g, lidocaine 750mg, prilocaine 750mg) or the reference formulation, lidocaine cream (EMLA®, 1g, lidocaine 25mg, prilocaine 25mg), in healthy volunteers.

To investigate the pharmacokinetic characteristics of a single oral dose of bisoprolol amlodipine tablets [test preparation, strength: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)] provided by Shenzhen Yujian Biotechnology Co., Ltd. in healthy study participants under fasting and postprandial conditions, compared with a single oral dose of bisoprolol amlodipine tablets [reference preparation, strength: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)] certified by Merck Kft under the same conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.

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.