Tolerability of new calcium sensitizer piperphentonamin continuous infusion in Chinese healthy volunteers
10.13699/j.cnki.1001-6821.2014.06.013
- VernacularTitle:盐酸椒苯酮胺在中国健康人体连续给药的耐受性研究
- Author:
Wei XUE
1
;
Ai-Xin SHI
;
Ru-Bing LI
;
Xiang-Yang YANG
;
Hua-Yin WAN
;
Fan DONG
;
Guo-Ying CAO
;
Yang LI
;
Min LI
;
Bei YAN
;
Xin HU
Author Information
1. 北京医院 药学部 药物临床风险与个体化应用评价北京市重点实验室
- Keywords:
calcium sensitizer;
continuous intravenous infusion;
tolera-bility;
piperphentonamine hydrochloride;
adverse event
- From:
The Chinese Journal of Clinical Pharmacology
2014;(6):511-513
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety and tolerability of continu-ous intravenous infusion of innovative calcium sensitizer piperphent-onamin ( PPTA) at a loading dose and a maintenance dose in healthy vol-unteers.Methods A randomized, open, single-center, phase I clini-cal trial in 11 healthy male and female subjects was conducted.Each subject was intravenously administered with a single loading dose of 0.1 mg· kg -1 for 20 min, and then a maintenance dose of 0.9 mg· kg -1 for 24 h.Safety and tolerance of PPTA were assessed by vital sign , dynamic electrocardiogram monitoring , physical examination , laboratory tests and eye exams, according to which adverse events ( AEs) were identified and recorded.The safety and tolerability were evaluated.Results Vital signs of all subjects were stable , and no QTc interval prolongation was observed during the trial.A total of 13 AEs were reported in 6 subjects , among which 9 AEs were the reflections of the effects of PPTA and all AEs were all relieved without treatment.Conclusion The regimen of in-travenous PPTA loading dose for 20 min and then a maintenance dose for 24 h is safe and tolerable.
