Bioequivalence of solifenacin succinate tablets in healthy Chinese volunteers

Hui Wang; Chang Cui; Shuang Yang; An Yao; Shuting WU; Xiaoyan Yang; Ling YE; Guoping Yang; Jie Huang; Hui Wang; Chang Cui; Shuang Yang; An Yao; Shuting WU; Xiaoyan Yang; Ling YE; Guoping Yang; Jie Huang; Zhi Zou; Zhi Tang; Dongsheng Ouyang

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Bioequivalence of solifenacin succinate tablets in healthy Chinese volunteers

Author: Hui WANG ¹ ; Chang CUI ¹ ; Shuang YANG ¹ ; An YAO ¹ ; Shuting WU ¹ ; Xiaoyan YANG ¹ ; Ling YE ¹ ; Guoping YANG ¹ ; Jie HUANG ¹ ; Hui WANG ² ; Chang CUI ² ; Shuang YANG ² ; An YAO ² ; Shuting WU ² ; Xiaoyan YANG ² ; Ling YE ² ; Guoping YANG ² ; Jie HUANG ² ; Zhi ZOU ³ ; Zhi TANG ³ ; Dongsheng OUYANG ³
Author Information

1. Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University
2. Research Center of Drug Clinical Evaluation of Central South University
3. Changsha Duxact Biotech Co, Ltd.
Publication Type:Journal Article
Keywords: Bioequivalence; LC-MS/MS; Pharmacokinetic; Solifenacin succinate
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(3):299-304
CountryChina
Language:Chinese
Abstract: AIM: To evaluate the bioequivalence of the test and reference preparations of solifenacin succinate tablets administered once orally under fasting and fed conditions in Chinese healthy volunteers. METHODS: The study was designed as single-center, randomized, open, self-crossover and twenty four healthy volunteers were recruited respectively in fasting and fed conditions. Subjects were assigned to receive a single oral of the test or reference formulation per period at a dose of 10 mg. The plasma concentration of solifenacin was analyzed by LC-MS/MS. The major pharmacokinetic parameters were calculated by WinNonlin 7.0, then the bioequivalence was evaluated.RESULTS: The main pharmacokinetic parameters of a single oral solifenacin succinate under fasting condition for test and reference preparation were as follows: C