Please use this identifier to cite or link to this item:
https://dspace.ctu.edu.vn/jspui/handle/123456789/54712
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 Losartan 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. |
URI: | https://dspace.ctu.edu.vn/jspui/handle/123456789/54712 |
ISSN: | 0866-7861 |
Appears in Collections: | Dược học |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
_file_ Restricted Access | 3.32 MB | Adobe PDF | ||
Your IP: 18.191.118.36 |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.