Bioequivalence of solifenacin succinate tablets in healthy Chinese volunteers / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
; (12): 299-304, 2021.
Article
de Zh
| WPRIM
| ID: wpr-1015067
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WPRO
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
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WPRIM
langue:
Zh
Texte intégral:
Chinese Journal of Clinical Pharmacology and Therapeutics
Année:
2021
Type:
Article