Data/hora: 05/06/2024 19:18:18

Provedor de dados: 	60	
País: 	Brazil	
Título: 	Pharmacokinetics, safety and tolerability of L-3-n-butylphthalide tablet after single and multiple oral administrations in healthy Chinese volunteers	
Autores: 	Wang,Meng; Zhang,Quan-ying; Hua,Wen-yan; Huang,Ming; Zhou,Wen-jia; Lou,Kun; Peng,Yue-ying.	
Data: 	2015-09-01	
Ano: 	2015	
Palavras-chave: 	L-3-n-butylphthalide/tablets/safety; L-3-n-butylphthalide/tablets/tolerability; L-3-n-butylphthalide/tablets/pharmacokinetics; Natural antioxidant.	
Resumo: 	L-3-n-butylphthalide (L-NBP) is a naturally occurring antioxidant, which can be used for the treatment of acute ischemic stroke and vascular dementia. This study evaluated the safety, tolerability and pharmacokinetics of L-NBP tablets in healthy Chinese volunteers. This was a single-center, randomized, double-blind, placebo-controlled, single- and multiple-dose study. Subjects were assigned to receive a single dose of L-NBP tablet at either 80, 160, 320, or 480 mg (n=40), or multiple doses of 160 mg twice daily for 7 days (n=12). Plasma samples were analyzed with LC-MS/MS. Pharmacokinetic parameters of L-NBP were calculated using non-compartmental analysis with WinNonlin software. Statistical analysis was performed using SPSS software. All adverse events (AEs) were mild and of limited duration; AEs in this study occurred less frequently and more mildly than AEs listed for the DL-NBP soft capsule. No serious adverse event (SAE), death or withdrawal from the study was observed. In the single-dose study, Cmax was reached at about 1 h, and the mean t1/2 was approximately 13.76 h. Area under curve (AUC) and Cmax increased with dose escalation, but dose proportionality was not observed over the range of 160 to 480 mg. In the multiple-dose study, the steady-state was reached within 3 days with slight accumulation. In summary, the L-NBP tablet was well tolerated in healthy Chinese subjects. Slight accumulation appeared after repeated doses.	
Tipo: 	Info:eu-repo/semantics/article	
Idioma: 	Inglês	
Identificador: 	http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000300525	
Editor: 	Universidade de São Paulo, Faculdade de Ciências Farmacêuticas	
Relação: 	10.1590/S1984-82502015000300004	
Formato: 	text/html	
Fonte: 	Brazilian Journal of Pharmaceutical Sciences  v.51 n.3 2015	
Fonte: 	info:eu-repo/semantics/openAccess