Pharmacokinetics and bioequivalence of domestic and inported indapamide sustained release tablet in healthy volunteers

Objective To evaluate the bioequivalence of domestic tablet and imported of indapamide sustained release tablet. Methods A single oral dose and multi - doses of indapamide sustained release tablet were given to 20 healthy male Chinese volunteers. The concentrations of indapamide were determined by HPLC - electrochemistry( EC) method. Results The main pharmacokinetic parameters of single dose of the two products were as follows:Cmax were (19.2 ±6. 3) and (18. 1 ±5. 6) ng · mL-1,tmax were (12. 3 ±2. 1) and (12. 7 ± 1.9) h, AUC0-72 were (528.2 ±264.0) and (514.5 ±210.2) ng · h · mL-1 for reference and test respectively. The relative bioavailablity was (100. 7 ± 16. 3)%. And the parameters of multi - doses were as follows; tmax were (10. 7 ± 1.8) and (10.8±2.3) h, Cmax were (34. 5 ±10. 7) and (36.0 ±11. 9) ng · mL-1,Cmax were (16.0±5.8) and (17.2±6.0) ng · mL-1, AUCSS were (568. 8 ± 198. 2) and (584. 7 ± 195. 5) ng · h · mL-1 ,F was (104. 2 ±12. 5)% . Conclusion The indapamide sustained release tablet of domestic and imported were bioequivalent .