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| Lv,Cheng-zhe; Huang,Ming; Zhang,Quan-ying; Zong,Shun-lin; Wang,Meng. |
| ABSTRACT Repirinast is a new, synthetic, disodium cromoglycate-like antiallergic agent for oral administration in humans. This study evaluated the safety, tolerability and pharmacokinetics of repirinast tablets in healthy Chinese volunteers. This was a phase I, open-label, randomized, single- and multiple-dose study. Subjects were assigned to receive a single dose of repirinast tablet at either 150, 300, or 450 mg, or multiple doses of 150 mg twice daily for 5 days. Plasma samples were analyzed with LC-MS/MS. Pharmacokinetic parameters of active metabolite MY-1250 (deesterified repirinast) were calculated using non-compartmental analysis with WinNonlin software. Statistical analysis was performed using SPSS software. All adverse events (AEs) were mild and... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Repirinast/safety/pharmacokinetics; Single dose; Multiple dose; China.. |
| Ano: 2018 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000200625 |
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| Wang,Meng; Zhang,Quan-ying; Hua,Wen-yan; Huang,Ming; Zhou,Wen-jia; Lou,Kun; Peng,Yue-ying. |
| 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... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: L-3-n-butylphthalide/tablets/safety; L-3-n-butylphthalide/tablets/tolerability; L-3-n-butylphthalide/tablets/pharmacokinetics; Natural antioxidant. |
| Ano: 2015 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000300525 |
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