Pharmacokinetics and relative bioequivalence of telmisartan tablets in Chinese healthy volunteers

Objective To study the relative bioavailability of telmisartan tablet in Chinese healthy volunteers and to evaluate its bioequivalence. Methods A single oral dose 80 mg of two telmisartan tablets was given to 20 healthy volunteers in a randomized cross-over study. The concentration of telmisartan in plasma were determined by HPLC method with fluorimetric detection. Results Finding revealed that the data of two formulations were fitted to a two-compartment open model. The main pharmacokinetic parameters of two formulations, reference and test tablets, were as follow: C max were (944.71± 376.08) and (852.72±333.78) ng·mL -1, t max were (0.98±0.60) and (1.28±0.65)h, t 1/2β were (28.78±13.88) and (25.83±9.25)h, AUC 0-twere (4.14±2.44) and (3.83±1.97) mg·h·L -1; AUC 0-∞ were (4.64±2.84) and (4.17±2.22)mg·h·L -1.The relative bioavalability of F 0-t and F 0-∞were (99.64±22.39)% and (97.97± 26.20)%, respectively. Conclusion The domestic and imported telmisartan tablets were bioequivalent .