Beijing Mingze Zhonghe Pharmaceutical Research Co., Ltd.

This study investigated the pharmacokinetic characteristics of a single application of flurbiprofen gel patch (test formulation T, specification: 12g of ointment and 40mg of flurbiprofen per patch (10.0cm×13.6cm)) provided by Anhui Jingming Pharmaceutical Co., Ltd., or flurbiprofen gel patch (reference formulation R, specification: 40mg of flurbiprofen per patch (area 13.6cm×10.0cm, ointment content 12g)) held by Mikasa Seiyaku Co., Ltd. The bioequivalence and safety of the two formulations were evaluated, and their adhesiveness and skin irritation were also investigated to provide a basis for the registration application of the test formulation.

This study aimed to investigate the pharmacokinetic characteristics of vardenafil hydrochloride orally disintegrating tablets (10 mg) developed by Beijing Mingze Zhonghe Pharmaceutical Research Co., Ltd. and manufactured by Huayi Pharmaceutical Technology (Anhui) Co., Ltd., after a single oral fasting dose. Using vardenafil hydrochloride orally disintegrating tablets (10 mg) manufactured by Alembic Pharmaceuticals Limited as a reference formulation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their bioequivalence in humans.

To investigate the pharmacokinetic characteristics of healthy subjects after a single application of one loxoprofen sodium gel patch provided by Anhui Jingming Pharmaceutical Co., Ltd. [test preparation T, specification: each patch (14cm×10cm) contains 10g of paste, containing 100mg of loxoprofen sodium (calculated as C15H17NaO3)] or one patch of loxoprofen sodium gel patch certified by LEAD CHEMICAL CO., LTD. [reference preparation R, trade name: LOXONIN ® PAP, specification: each patch (14cm×10cm) contains 10g of paste, containing 100mg of loxoprofen sodium (calculated as C15H17NaO3)], and to evaluate the bioequivalence and safety of the two preparations. At the same time, the adhesion and skin irritation of the two preparations were investigated to provide a basis for the registration application of the test preparation.