甲磺酸溴隐亭片在健康受试者中随机、开放、单剂量、四周期、两序列、完全重复交叉的餐后状态下生物等效性试验
[Translation] A randomized, open-label, single-dose, four-period, two-sequence, completely repeated crossover bioequivalence study of bromocriptine mesylate tablets in healthy subjects under the fed state
研究单次餐后口服成都瑞尔医药科技有限公司研制、杭州民生药业股份有限公司生产的甲磺酸溴隐亭片〔2.5 mg(以溴隐亭(C32H40BrN5O5)计)〕的药代动力学特征;以Bridging Pharma GmbH持证、DOPPEL Farmaceutici S.r.l.生产的甲磺酸溴隐亭片〔Parlodel®,2.5 mg(以溴隐亭(C32H40BrN5O5)计)〕为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The pharmacokinetic characteristics of bromocriptine mesylate tablets [2.5 mg (calculated as bromocriptine (C32H40BrN5O5))] developed by Chengdu Ruier Pharmaceutical Technology Co., Ltd. and produced by Hangzhou Minsheng Pharmaceutical Co., Ltd. after a single oral administration after meal were studied; bromocriptine mesylate tablets [Parlodel®, 2.5 mg (calculated as bromocriptine (C32H40BrN5O5))] certified by Bridging Pharma GmbH and produced by DOPPEL Farmaceutici S.r.l. were used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.
100 Clinical Results associated with Chengdu Ruier Pharmaceutical Technology Co., Ltd.
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