Shanghai Asia Pioneer Pharmaceuticals Co. Ltd.

Based on the Phase II (A, B) clinical trials of bifonazole chlorhexidine spray, a single-center, randomized, open trial method was used to further verify the efficacy and safety of bifonazole chlorhexidine spray in the treatment of superficial fungal diseases (tinea pedis) accompanied by bacterial infection. A single-center, randomized, open, Phase II (C) clinical trial of bifonazole solution and fusidic acid cream was conducted to provide reference data for the Phase III clinical trials of the drug.

The purpose of the trial is to study the therapeutic effect and safety of different concentrations of compound bifonazole solution on superficial fungal diseases accompanied by bacterial infection, and to provide a basis for the design of Phase III clinical trial and the determination of the dosage regimen.

Primary objective: To evaluate the bioequivalence of the test preparation flurbiprofen axetil injection produced by Shanghai Pharma New Asia Pharmaceutical Co., Ltd. and the reference preparation flurbiprofen axetil injection (Japanese brand name ROPION®, English brand name ROPION®) produced by Japan Research Pharmaceutical Co., Ltd. in healthy adult subjects in the fed state. Secondary objective: To evaluate the safety of flurbiprofen axetil injection after a single intravenous injection in healthy Chinese subjects.