Pharmacokinetics and bioequivalence study of indapamide sustained-release capsules in human whole blood

OBJECTIVE To study the pharmacokinetics and bioequivalence of indapamide test capsules and reference tablets in healthy volunteers. METHODS A single oral dose of 1.5 mg test or reference preparation was given to 20 healthy volunteers in a randomized two-period study. LC/MS/MS method was developed for the determination of indapamide in human whole blood. The pharmacokinetics parameters were obtained by DAS software. RESULTS The main pharmacokinetics parameters of test capsules and reference tablets were as follows:Cmax were (38.2±14.6) and (1.1±7.6) ng·mL-1;Tmax were(11.4±3.3) and (8.0±3.0) h;t1/2ke were (19.7±2.3) and (19.7±2.8)h;AUC0-96 were (1 252.8±404.3) and (1 267.5±278.8) ng·h·mL-1;AUC0-∞were (1 308.0±424.6) and (1 319.4±292.4)ng·h·mL-1;The relative bioavalability of the test capsules was (97.5±14.5)%. CONCLUSION The results show that the test capsules of indapaminde and the reference tabtels are bioequivalent.