Tolerance study of ulinastatin injection in Chinese healthy volunteers
10.13699/j.cnki.1001-6821.2015.21.008
- VernacularTitle:乌司他丁在中国健康成年受试者中的耐受性研究
- Author:
Yang LIU
1
;
Qian WANG
;
Hui-Ying ZHAO
;
Dao-Li JIANG
;
Yan WANG
;
Jia-Peng LI
;
Zhong-Na WEI
;
You-Zhong AN
;
Lian-Chen RONG
;
Ling XU
;
Li-Bo ZHAO
;
Yi FANG
Author Information
1. 北京大学 人民医院 药剂科
- Keywords:
ulinastatin;
Chinese healthy volunteer;
multi-dose;
safety;
tolerance
- From:
The Chinese Journal of Clinical Pharmacology
2015;(21):2111-2113
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety and tolerance of multi-dose of ulinastatin ( UTI ) injection in Chinese healthy volunteers. Methods This is a parallel, randomized, double -blind, placebo -controlled, multi-dose study, and 24 health volunteers were randomized into A, B, C three dose groups.In each group, 2 subjects were adminis-trated with placebo and 6 subjects with UTI.Each health volunteer re-ceived four doses a day, with interval period of 3 h.The health volun-teers in group A, B and C were administrated 6 ×105 , 9 ×105 and 12 ×105 U UTI at each dose, respectively.Each subject received the first dose of UTI by intravenous infusion over 30 minutes at a stable rate using an infusion pump, and the following three doses via intravenously drip at a rate of 5 ×105 U/0.5 h.Adverse events ( AEs) , vital signs and laboratory tests throughout the study were used to assess the safety and tolerance.Results All the 24 healthy volunteers finished the study. After administration of UTI, 5 cases of fibrinogen(FIB) with clinical sig-nificance occurred in C group and placebo group, other test results were normal or abnormal with no clinical significance.During the trail, no serious AEs were observed.No AEs occurred in the group A and group B.Only 2 cases of slight and mild diarrhea, probably related to the drug, and 1 case of periumbilical abdominal pain, probably unrelated to the drug, were observed in group C ( except the placebo group);3 and 2 cases of FIB, probably unrelated to the drug, were observed in group C and placebo group, respectively.All AEs were of grade I according to the common terminology criteria for adverse events ( CTCAE) version 4.0 and required no medical intervention.Conclusion Multi-dose ( qid) ranged from 6 ×105 U to 12 ×105 U of UTI in Chinese healthy volunteers was safe and well tolerant.It is recommended that dose up to 12 ×105 U ( qid) may be tested for the follow-up clinical trials.
