Phase Ⅰtolerance clinical trail of intravenous injection of levornidazole in Chinese healthy volunteers
10.13699/j.cnki.1001-6821.2015.23.011
- VernacularTitle:注射用磷酸左奥硝唑酯二钠的Ⅰ期临床耐受性试验
- Author:
Jiang CAO
1
;
He-Kun MEI
;
Xue-Wei JIANG
;
Ming-Jing TANG
;
Hui NIU
;
Kai WANG
;
Ke WEN
;
Rui WANG
;
Jin WANG
;
Pei-Lan WANG
Author Information
1. 中国人民解放军总医院 药物临床研究中心
- Keywords:
levornidazole;
single intravenous injection;
tolerance trail
- From:
The Chinese Journal of Clinical Pharmacology
2015;(23):2311-2313
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the maximum tolerated dose of levornidazole with phosphate ester disodium in Chinese healthy volun-teers.Methods This was a single-center, randomized, blinded, pla-cebo-controlled trial.Healthy volunteers were accepted a single dose intravenous injection of levornidazole in each group with dose escalation design to determine the maximum tolerated dose of single dose.A total of 40 healthy volunteers were screened and equally divided into five groups ( half were male and half female ) , two cases ( one man and woman ) of each group were randomly chosen to receive placebo.The dosage of each group were 1000, 1500, 2000, 2500,3000 mg, separately.Changes in vital signs, electrocardiogram and laboratory tests were recorded, and adverse events were also observed and recorded.Results Changes of vital signs and eletrocariogram were without clinical significance before and after administration.White blood cell count were reduced in 1 pa-tient without any symptoms and signs, which might be related to drugs.A total of 7 cases of adverse events occurred, which were mild, short-du-ration, and disappeared without intervention.Conclusion Good tolera-bility and safety was shown in single dose of levornidazole range from 1000-3000 mg, the maximum tolerated single dose was 3000 mg.Dos-age recom-mended in phaseⅡclinical trial is 2000 mg? d-1 .
