Research Article
American Journal of BioMedicine
Volume 12, Issue 1, 2024, Pages 21-32 10.18081/2333-5106/2024.12/21
Yung-Cho Hsu1 , Shu-Chang Hsiao ,Hong Wen Huang, Ping Yang Ho, Ching-Yi Lin, Ta-Chun Chuang *
Received 24 August 2023; revised 30 October 2023; accepted 14 December 2023; published 31 March 2024
Abstract
Imipramine is an antidepressant drug (ADs) that shows therapeutic efficacy in a maximum of 60–80% of patients who have experienced a major depressive episode (unipolar or bipolar). The purpose of the study was to investigate the pharmacokinetics of a multi-oral dose of Imipramine 25 mg tablet in a Taiwan healthy population. The study was a standard two-way, crossover, randomized, and single dose daily for 5 days study with a two-week washout period in 30 healthy volunteers who received 25 mg imipramine tablets (test and reference formulation). After drug administration, blood samples were taken according to the planned times over a period of 24 hours. The plasma concentrations of Imipramine were determined using the validated high-performance liquid chromatography method with ultraviolet detection. All the pharmacokinetic parameters for Imipramine in healthy volunteers were calculated using nonlinear mixed-effect modeling and standard non-compartmental methods. Values (relative standard error (RSE) %) for first-order absorption rate constant (Ka), oral clearance (Cl/F), and apparent volume of distribution (Vd/F) were 1.05 (7.11) 1/h, 6.99(0.27) L/h, and 71.7.9(4.80) L. The median for the time to peak plasma Imipramine concentration (Tmax) for the test and reference drug was 2(1.1-4) hours and 4(1.9-5) hours respectively. In conclusion, the imipramine pharmacokinetic model in the Taiwan healthy population was similar to other studied populations. .
Keywords: Imipramine; Relative standard error; Pharmacokinetic parameters
Copyright © 2024 Chun Chuang, et al. This article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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How to cite
Cho Hsu Y, Chang Hsiao S, Wen Huang H, Yang Ho P, Yi Lin C, Chun Chuang T. Population pharmacokinetic study of Imipramine in Taiwan people healthy Volunteers. American Journal of BioMedicine 2024; 12(1):21-32.
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