/ CompletedNot Applicable 巴氯芬口服溶液(5mg/5mL)在健康受试者中空腹及餐后状态下的单剂量、随机、开放、两周期、两序列交叉设计的生物等效性试验
[Translation] A single-dose, randomized, open-label, two-period, two-sequence crossover bioequivalence study of baclofen oral solution (5 mg/5 mL) in healthy subjects under fasting and fed conditions
主要目的:研究空腹和餐后单次口服巴氯芬口服溶液受试制剂(规格:5mg/5mL,中孚药业股份有限公司生产,山东道齐生物医药科技有限公司提供)与巴氯芬口服溶液参比制剂(Lioresal®,规格:5mg/5mL,Novartis Pharmaceuticals UK Limited持证,山东道齐生物医药科技有限公司提供)在中国健康受试者体内的药代动力学行为,评价空腹及餐后口服两种制剂的生物等效性。
次要目的:评价中国健康受试者空腹和餐后单次口服巴氯芬口服溶液受试制剂(T)和参比制剂(R)后的安全性及口感。
[Translation] Primary objective: To study the pharmacokinetic behavior of the test formulation of baclofen oral solution (specification: 5 mg/5 mL, produced by Zhongfu Pharmaceutical Co., Ltd., provided by Shandong Daoqi Biopharmaceutical Technology Co., Ltd.) and the reference formulation of baclofen oral solution (Lioresal®, specification: 5 mg/5 mL, licensed by Novartis Pharmaceuticals UK Limited, provided by Shandong Daoqi Biopharmaceutical Technology Co., Ltd.) in healthy Chinese subjects after single oral administration on an empty stomach and after a meal, and to evaluate the bioequivalence of the two formulations after oral administration on an empty stomach and after a meal.
Secondary objective: To evaluate the safety and taste of the test formulation (T) and the reference formulation (R) of baclofen oral solution in healthy Chinese subjects after single oral administration on an empty stomach and after a meal.
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