Pharmacokinetics of lansoprazole injection after a single dose in Chinese healthy volunteers

Objective To study the pharmacokinetics of lansoprazole injection with a single intravenous injection administration using a constant speed in Chinese healthy volunteers.Methods Twelve healthy volunteers were enrolled and each of whom was administered with single dose of 15,30,and 65 mg lansoprazole injection in 3 cross periods.The plasma concentrations of lansoprazole were determined by HPLC-UV.The pharmacokinetic parameters of three dose (15, 30, 65 mg) lansoprazole were calculated by 3P97 software. Results The plasma concentration-time curve fits two compartment model. After single iv dose of 15,30,and 65 mg lansoprazole injection,12 volunteers, the main pharmacokinetic parameters of three doses (15, 30, 60 mg)lansoprazole were as follows: Cmax were (1105.65±506.24), (2171.33±799.02), (4070.53±643.04) μg·L-1; t1/2 were (1.63±0.86), (2.30±2.01), (1.90±1.19) h; AUC0-12 were (991.16±814.49), (3495.87±1770.92), (8351.14±2599.90) μg·h·L-1 respectively. Conclusion After administration of single-dose lansoprazole,it was safe within the dosage ranged from 15 to 60 mg, and there was no significant difference of physiological disposition between the male and female.