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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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