Nghiên cứu dược động học và đánh giá tương đương sinh học viên nén bao phim Losartan kali 100 mg sản xuất tại Việt Nam

Abstract

The pharmacokinetics and bioequivalence of the two preparations of Losartan 100 mg tablets were evaluated by a two-way cross-over randomized study. The study involved 24 Vietnamese healthy volunteers taking a single oral dose. Losartan and its main active metabolite in the human plasma samples collected at given intervals of time after administration (0-36h) were assayed by high performance liquid chromatography (HPLC) with positive turbo ion spray ionization tandem mass spectrometry detection (HPLC-MS). The observed pharmacokinetic parameters including area under the curve total (AUC) and to infinity (AUCmax), peak plasma concentration (Cmax), time to attain peak (Tmax), and elimination half-life (t1/2) were determined and analyzed statistically. Statistically, no significant differences were recored in Cmax and AUC of both losartan and its active metabolite. In the bioequivalence range of 0.8 - 1.25 confidence limits calculated for AUC and Cmax of losartan and its metabolitere were 90 % and 95 %, respectively. These finding confirmed the tested formulation to be well bioequivalent to the reference with respect to losartan and its main active metabolite.