Pharmacokinetics and bioequivalence of three telmisartan preparations in healthy Chinese volunteers

Objective: To evaluate the pharmacokinetics and bioequivalence of domestic telmisartan capsules and tablets (test samples) with imported telmisartan tablets ( reference samples) . Method : This was an open randomized, three periods cross over study that recruited eighteen healthy male volunteers. Each volunteer were randomly administered with a single oral dose of telmisartan (test or reference samples) 80 mg. The plasma concentrations of telmisartan were determined by LC-MS-MS. A non-compartmental method was used in analysis of pharmacokinetic parameters. Logarithm-transformed Cmax and AUC were analyzed by the analysis of variance (ANOVA) and 90% confidence intervals. Results; The main pharmacokinetic parameters of domestic telmisartan capsules, tablets and imported telmisartan tablets were as following: Cmax(1016.3±571.7), (869. 7±623. 8) , (905. 7±583. 4) ng·mL-1; Tmax(1.5±1.0), (1.5±0.6), (1.6±1.1)h; AUC0-t(7 372±3 955), (7373±4347), (6774±3 758)ng·h·mL-1; AUC0-∞(8 432±4 946), (8 623±5687), (7 502±4 663 ) ng·h·mL-1; t1/2 (24. 9±9.2), (24. 5±11.9), (23. 0±6. 5) h, respectively. Conclusion: The domestic telmisartan capsules and tablets are bioequivalent with the imported telmisartan tablets.