[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, self-crossover controlled trial designed to evaluate the bioequivalence of loxoprofen sodium patch in Chinese healthy subjects when used in the fasting state.
以湖南迪诺制药股份有限公司提供的洛索洛芬钠贴剂为受试制剂,按生物等效性试验的有关规定,与Lead Chemical Co., Ltd.持证的参比制剂洛索洛芬钠贴剂(商品名:乐松®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的:观察受试制剂洛索洛芬钠贴剂和参比制剂洛索洛芬钠贴剂(商品名:乐松®)在健康受试者中的安全性、黏附力和皮肤刺激性。
[Translation] The loxoprofen sodium patch provided by Hunan Dino Pharmaceutical Co., Ltd. was used as the test formulation. Following bioequivalence testing regulations, the absorption rate and extent of the two formulations in healthy volunteers were compared with the reference formulation, loxoprofen sodium patch (trade name: Lesong®), licensed by Lead Chemical Co., Ltd., to investigate their bioequivalence.
Secondary objectives: To investigate the safety, adhesion, and skin irritation of the test and reference formulations, loxoprofen sodium patches (trade name: Lesong®), in healthy volunteers.