[Translation] A randomized, open-label, postprandial, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence pilot clinical study of enteric-coated ademethionine butanedisulfonate tablets (0.5 g) in healthy Chinese subjects
主要研究目的:按有关生物等效性试验的规定,选择 ABBOTT LABORATORIES (M) SDN. BHD 为持证商的丁二磺酸腺苷蛋氨酸肠溶片(商品名:Transmetil,规格:0.5g)为参比制剂,对吉林省德商药业股份有限公司生产并提供的受试制剂丁二磺酸腺苷蛋氨酸肠溶片(规格:0.5g)进行餐后给药人体生物等效性预试验,估算餐后给药后受试制剂和参比制剂的药代动力学特征,为正式试验的设计提供一定的参考依据。次要研究目的:观察健康志愿受试者口服受试制剂丁二磺酸腺苷蛋氨酸肠溶片(规格:0.5g)和参比制剂丁二磺酸腺苷蛋氨酸肠溶片(商品名:Transmetil,规格:0.5g)的安全性。
[Translation] The main purpose of the study: According to the relevant provisions of the bioequivalence test, ABBOTT LABORATORIES (M) SDN. BHD was selected as the reference preparation, and the test preparation succinate succinate enteric-coated tablets (specification: 0.5g) produced and provided by Jilin Deshang Pharmaceutical Co., Ltd. was used for the preliminary human bioequivalence test after meal administration, and the pharmacokinetic characteristics of the test preparation and the reference preparation after meal administration were estimated, so as to provide a certain reference basis for the design of the formal test. The secondary purpose of the study: To observe the safety of the test preparation succinate succinate enteric-coated tablets (specification: 0.5g) and the reference preparation succinate succinate enteric-coated tablets (trade name: Transmetil, specification: 0.5g) taken orally by healthy volunteers.