Study on the Bioequivalence of 2 Kinds of Domestic Telmisartan Preparations in Human

OBJECTIVE: To study the bioequivalence of Telmisartan capsule and Telmisartan tablet. METHODS: A randomized crossover design was performed in 20 healthy volunteers. A single oral dose of either domestic Telmisartan capsules (test preparation) or imported Telmisartan tablets (reference preparation) 80 mg were administered. Plasma concentration of telmisartan was measured by HPLC. The pharmacokinetic parameters were measured by 3p97 software. RESULTS: Blood concentration-time curves of test preparation or reference preparation fitted to one-compartment open model. Pharmacokinetic parameters were as follows: t1/2Ke were(74.23±25.11)h and (79.18±23.27)h, tmax(2.08±1.64) h and (2.02±0.86) h,cmax(2.10±1.36)μg·mL-1 and (1.95±1.08)μg·mL-1, AUC0～144 h(116.25±55.97) μg·h·mL-1 and (123.94±65.66) μg·h·mL-1, respectively. The relative bioavailability of domestic capsules was (93.80±12.24)%, compared with imported tablet. There was no significant difference in pharmaceutical parameters through variance analysis, t-test and 1-2α confidence interval method. CONCLUSION: Domestic Telmisartan capsule and imported Telmisartan tablet are bioequivalent.