Welcome to Chinese Journal of Clinical Pharmacology and Therapeutics,Today is Chinese

Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2014, Vol. 19 ›› Issue (7): 785-788.

Previous Articles     Next Articles

Pharmacokinetics, pharmacodynamics and safety of bivalirudin sequential regimen in Chinese healthy volunteers

CHAI Dong1, WANG Rui2, BAI Nan2, MEI He-kun2   

  1. 1 Department of Pharmacy, Hainan Branch of PLA General Hospital, Sanya 572013, Hainan;
    2 Department of Drug Clinical Trial Center of PLA General Hospital, Beijing 100853,China
  • Received:2013-09-07 Revised:2014-06-20 Published:2014-07-21

Abstract: AIM: To investigate the reasonable sequential regimen of bivalirudin in clinic. METHODS: 12 Chinese healthy volunteers were selected. During bivalirudin administration (0.75 mg/kg bolus followed by a 1.75 mg·kg-1·h-1 infusion for 4 h), blood samples were collected in regular time, and blood concentration of bivalirudin, active coagulation time (ACT) and function were measured. Then the primary pharmacokinetic parameters were caculated using WinNonlin 5.2.1. The adverse events were observed during the clinical trial.RESULTS:The time-effect curves and time-concentration curve of bivalirudin in this clinical trial were paralleled. The ACT was 220-240 s steadily respectively. During the clinical trial, there were no serve adverse events, and the coagulation function recovered to normal after 24 h. CONCLUSION: Bivalirudin sequential regimen (0.75 mg/kg bolus followed by a 1.75 mg·kg-1·h-1 infusion for 4 h) is effective and safe for clinic.

Key words: bivalirudin, sequential regimen, active coagulation time (ACT)

CLC Number: