PhaseⅠclinical tolerance study of Picika oral solution in healthy volunteers
10.13699/j.cnki.1001-6821.2014.10.013
- VernacularTitle:谱圣康口服液I期临床人体耐受性试验研究
- Author:
Feng DUAN
1
;
Jing-Feng BI
;
Ben-Chao CHEN
;
Zhen-Zhen ZHU
;
Bin SUN
;
Zhen CHEN
;
Yu ZHANG
;
Yan-Yan CHU
;
Li ZHANG
;
Min WANG
;
Wen-Shu LI
;
Cheng JIN
;
Zhen-Man WEI
Author Information
1. 解放军第 302 医院 新药临床试验中心
- Keywords:
Picika oral solution;
phase Ⅰ clinical;
tolerance
- From:
The Chinese Journal of Clinical Pharmacology
2014;(10):912-914
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the tolerability and safety of single and multiple doses of Picika oral solution in healthy volunteers.Methods A single center, randomized, single -blind, placebo -controlled, dose -escalation study was designed.50 patients were given single dose, and 10 cases were given multiple doses.All of them had half male and fe-male.Single -dose group: 20 mL(4 subjects), 40 mL(6 subjects), 60 mL(10 subjects; 2 using placebo), 90 mL(10 subjects; 2 using place-bo), 120 mL (10 subjects ; 2 using placebo), 160 mL (10 subjects; 2 using placebo); multiple doses group: 10 subjects(2 using placebo), 40 mL? times-1 , tid, continuous medication for 10 days.Results Of the sixty healthy subjects enrolled , 58 finally completed the trial, and two shed.One case (female) of adverse event in single -dose 160 mL group was reported: her ctivated partial thromboplastin time (APTT) was ab-normal with clinical significance.It may not be associated with the medi-cation.In multiple doses group, one case of abdominal pain (female) was reported, may not be associated with the medication.Conclusion Single and multiple doses of Picika oral solution are safe and well tolera -ted in healthy subjects.
