[Translation] A single-center, randomized, open-label, fasting/postprandial, single-dose, two-cycle, two-sequence, self-crossover controlled human bioequivalence study of carbocisteine tablets in healthy adult subjects
主要研究目的:以广州欧化药业有限公司持证、广东华南药业集团有限公司生产的羧甲司坦片(规格:0.25g)为受试制剂,以杏林製薬株式会社生产的羧甲司坦片(商品名:ムコダイン ,规格:250mg)为参比制剂,研究受试制剂与参比制剂的吸收速度和吸收程度,评价两制剂在空腹/餐后条件下单次给药时的生物等效性。
次要研究目的:观察在空腹/餐后条件下单次口服两制剂在健康受试者中的安全性。
[Translation] Main research purpose: Carbocysteine tablets (specification: 0.25g) produced by Guangzhou Ouhua Pharmaceutical Co., Ltd. and produced by Guangdong Huanan Pharmaceutical Group Co., Ltd. were used as the test preparation. Carbocysteine tablets produced by Xinglin Pharmaceutical Co., Ltd. Tan tablets (trade name: Mokuno, specification: 250mg) are reference preparations. The absorption speed and degree of absorption of the test preparation and the reference preparation are studied, and the bioequivalence of the two preparations when single administration under fasting/postprandial conditions is evaluated. effectiveness.
Secondary study objectives: To observe the safety of a single oral administration of two formulations in healthy subjects under fasting/postprandial conditions.