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Title: 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
Authors: Tạ, Mạnh Hùng
Đoàn, Cao Sơn
Lê, Thị Thu Huyền
Trần, Hoàng
Phan, Thị Nghĩa
Hà, Thị Tuyển
Keywords: Bioequivalence
Active metabolite
Vietnamese volunteer
Issue Date: 2018
Series/Report no.: Tạp chí Dược học;Số 512 .- Tr.10-13
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.
ISSN: 0866-7861
Appears in Collections:Dược học

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