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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 / Tạ Mạnh Hùng, Đoàn Cao Sơn, Lê Thị Thu Huyền, Trần Hoàng, Phan Thị Nghĩa, Hà Thị Tuyển // Tạp chí Dược học . - 2018. - tr. 10-13. - ISSN:



Ký hiệu phân loại (DDC): 615
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 (AUCt) and to infinity (AUCinf), 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.
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