In:
Fundamental & Clinical Pharmacology, Wiley, Vol. 31, No. 1 ( 2017-02), p. 120-125
Kurzfassung:
Sulcardine sulfate (Sul) is a novel anti‐arrhythmic agent as a potential treatment for atrial fibrillation and ventricular arrhythmias. This study was conducted to investigate the pharmacokinetic profile, safety, and tolerability of Sul in healthy Chinese subjects. In this open‐label, single‐dose, randomized study, 10 healthy subjects were assigned to receive Sul doses of 200, 400, and 800 mg under fasting conditions (Cohorts A, B, and C, respectively) or 400 mg under fed conditions (Cohort D). The study incorporated a crossover design, separated by a seven‐day washout period. Blood samples were collected before treatment and at successive time intervals up to 48 h after treatment. Sul concentrations in plasma samples were determined using a validated LC ‐ MS / MS method. Tolerability was determined by clinical evaluation and adverse event ( AE ) monitoring. Pharmacokinetic results demonstrated that C max and AUC (0– t ) of Sul increased with an increasing dose. The mean t 1/2 values for Cohorts A, B, and C were 16.85, 17.66, and 11.87 h, respectively. No statistically significant differences were observed between men and women for the main pharmacokinetic parameters, with the exception of t 1/2 in Cohorts B and C. No significant differences were observed in the absorption and bioavailability of Sul between the fed and fasted states ( P 〉 0.05). Four subjects reported mild AE s during the study. No serious AE s were reported. Sul was shown to be safe and well tolerated in healthy Chinese subjects. Pharmacokinetics studies demonstrated that Sul has adequate oral absorption and bioavailability properties.
Materialart:
Online-Ressource
ISSN:
0767-3981
,
1472-8206
DOI:
10.1111/fcp.2017.31.issue-1
Sprache:
Englisch
Verlag:
Wiley
Publikationsdatum:
2017
ZDB Id:
2006242-4
SSG:
15,3