Bioequivalence of lisinopril tablets in health volunteers

Objective:To study the pharmacokinetics and bioequivalence of lisinopril tablets made in China (test) vs,imported (reference).Methods:20 healthy male volunteers were received a single crossover dose of the test tablets (20 mg) or reference tablets.The plasma samples were collected from the volunteers to measure the blood lisinopril concentration using a LC-MS method.Results:The pharmacokinetic parameters of test and reference lisinopril were C_(max)(93.85±30.79) vs.(101.56±35.84)ng·mL·~(-1);AUC_(0～96h)(1690.26±528.20) vs.(1729.13±568.90)ng·h·mL~(-1);T_(max) (6.6±0.9) vs.(6.3±1.0) h;and t_(1/2)(16.28±2.51) vs.(15.87±2.80 ) h,respectively;the P values of these parameters showed no significant difference.The relative bioavailability of the test lisinopril was (98.6±8.7) %.Conclusion:The test lisinopril is bioequivalent to reference lisinopril.