[Translation] A randomized, open-label, two-sequence, four-cycle, fully replicated cross-over design bioequivalence trial of carlevodopa extended-release tablets in Chinese healthy subjects under fasting and postprandial conditions
主要研究目的
研究空腹和餐后状态下单次口服卡左双多巴缓释片(卡比多巴50mg,左旋多巴200mg,江苏和晨药业有限公司提供)与参比制剂(卡比多巴50mg,左旋多巴200mg,息宁®;持证商:MSD Sharp & Dohme GmbH)后卡比多巴、左旋多巴在中国健康受试者体内的药代动力学(PK)特征,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要研究目的
评价中国健康受试者空腹和餐后状态下,单次口服受试制剂卡左双多巴缓释片和参比制剂卡左双多巴缓释片后的安全性。
[Translation] Main research purpose
Study the single oral administration of carbidopa sustained-release tablets (carbidopa 50 mg, levodopa 200 mg, provided by Jiangsu Hechen Pharmaceutical Co., Ltd.) and the reference preparation (carbidopa 50 mg, levodopa 200 mg) in the fasting and postprandial state Pharmacokinetic (PK) characteristics of carbidopa and levodopa in Chinese healthy subjects after administration of levodopa 200 mg, Xining®; Licensee: MSD Sharp & Dohme GmbH), evaluating fasting and postprandial Bioequivalence of the two formulations administered orally under state.
Secondary research purpose
To evaluate the safety of Chinese healthy subjects after a single oral administration of the test preparation Levodopa extended-release tablets and the reference preparation Levodopa extended-release tablets in fasting and postprandial states.