[Translation] A single-center, randomized, open-label, single-dose, two-cycle, two-sequence, double-crossover bioequivalence trial of lidocaine gel patch in healthy subjects
主要目的:以利多卡因的体内药代动力学参数(Cmax与AUC)为生物等效性的评价指标,在中国健康受试者外用条件下评估受试制剂(海南回元堂药业有限公司生产的利多卡因凝胶贴膏,规格5%)和参比制剂(Teikoku Seiyaku Co., Ltd.生产的利多卡因凝胶贴膏,规格5%,商品名:Lidoderm®)的生物等效性;以利多卡因的平均黏附力得分为非劣效的评价指标,在中国健康受试者外用条件下评估受试制剂和参比制剂的非劣效性。
次要目的:观察中国健康受试者外用条件下受试制剂和参比制剂的皮肤刺激性和安全性。
[Translation] Main purpose: Using the in vivo pharmacokinetic parameters (Cmax and AUC) of lidocaine as the evaluation index of bioequivalence, to evaluate the test preparation under the condition of external use in Chinese healthy subjects (Hainan Huiyuantang Pharmaceutical Co., Ltd. Bioequivalence of the manufactured lidocaine gel patch, strength 5%) and the reference preparation (lidocaine gel patch manufactured by Teikoku Seiyaku Co., Ltd., strength 5%, trade name: Lidoderm®) The average adhesion score of lidocaine was used as the non-inferiority evaluation index to evaluate the non-inferiority of the test preparation and the reference preparation under the condition of external use in Chinese healthy subjects.
Secondary objective: To observe the skin irritation and safety of the test and reference preparations under topical conditions in Chinese healthy subjects.