Pharmacokinetics and safety of repirinast tablets in healthy Chinese subjects

Pharmacokinetics and safety of repirinast tablets in healthy Chinese subjects

Blog Article

ABSTRACT chrysler 300 phantom grill 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 igora 9.5-18 using SPSS software.All adverse events (AEs) were mild and of limited duration.

No serious adverse event (SAE), death or withdrawal from the study was observed.In the single-dose study, Cmax was reached at about 0.75 hour, and the mean t1/2 was approximately 16.21 hours.

Area under curve (AUC) and Cmax increased with dose escalation, but dose proportionality was not observed over the range of 150 to 450 mg.In the multiple-dose study, the steady-state was reached within 3 days with no accumulation.Repirinast tablet was well tolerated in healthy Chinese subjects.