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Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study
PURPOSE: The aim of this study was to evaluate the dose-proportional pharmacokinetic characteristics of pregabalin following the administration of GLA5PR GLARS-NF1 tablets (150, 300, 450, and 600 mg) in the fed state. SUBJECTS AND METHODS: An open-label, randomized, single-dose, parallel study was c...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6187918/ https://www.ncbi.nlm.nih.gov/pubmed/30349198 http://dx.doi.org/10.2147/DDDT.S167668 |
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author | Shin, Kwang-Hee Jeon, Ji-Young Jang, Kyungho Kim, Tae-Eun Kim, Min-Gul |
author_facet | Shin, Kwang-Hee Jeon, Ji-Young Jang, Kyungho Kim, Tae-Eun Kim, Min-Gul |
author_sort | Shin, Kwang-Hee |
collection | PubMed |
description | PURPOSE: The aim of this study was to evaluate the dose-proportional pharmacokinetic characteristics of pregabalin following the administration of GLA5PR GLARS-NF1 tablets (150, 300, 450, and 600 mg) in the fed state. SUBJECTS AND METHODS: An open-label, randomized, single-dose, parallel study was conducted in 40 eligible subjects who were randomly assigned to receive a single 150, 300, 450, or 600 mg dose of GLA5PR GLARS-NF1. Serial blood samples were collected before and after dosing for 36 hours, and plasma concentrations were determined using liquid chromatography-tandem mass spectrometry. Safety profiles were evaluated throughout the study (trial registration number: NCT02327000). RESULTS: Thirty-seven subjects completed the studies. The area under the plasma concentration-time curve up to the last measurable concentration of pregabalin exhibited dose proportionality following administration of GLA5PR GLARS-NF1 tablets from 150 to 600 mg while its maximum plasma concentration showed dose proportionality at a dose range of 150–450 mg. The safety evaluations showed no clinically significant finding after administration of GLA5PR GLARS-NF1 tablets (150, 300, 450, and 600 mg) in the fed state. CONCLUSIONS: The dose-proportional properties of GLA5PR GLARS-NF1 150–450 mg tablets were determined. |
format | Online Article Text |
id | pubmed-6187918 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-61879182018-10-22 Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study Shin, Kwang-Hee Jeon, Ji-Young Jang, Kyungho Kim, Tae-Eun Kim, Min-Gul Drug Des Devel Ther Original Research PURPOSE: The aim of this study was to evaluate the dose-proportional pharmacokinetic characteristics of pregabalin following the administration of GLA5PR GLARS-NF1 tablets (150, 300, 450, and 600 mg) in the fed state. SUBJECTS AND METHODS: An open-label, randomized, single-dose, parallel study was conducted in 40 eligible subjects who were randomly assigned to receive a single 150, 300, 450, or 600 mg dose of GLA5PR GLARS-NF1. Serial blood samples were collected before and after dosing for 36 hours, and plasma concentrations were determined using liquid chromatography-tandem mass spectrometry. Safety profiles were evaluated throughout the study (trial registration number: NCT02327000). RESULTS: Thirty-seven subjects completed the studies. The area under the plasma concentration-time curve up to the last measurable concentration of pregabalin exhibited dose proportionality following administration of GLA5PR GLARS-NF1 tablets from 150 to 600 mg while its maximum plasma concentration showed dose proportionality at a dose range of 150–450 mg. The safety evaluations showed no clinically significant finding after administration of GLA5PR GLARS-NF1 tablets (150, 300, 450, and 600 mg) in the fed state. CONCLUSIONS: The dose-proportional properties of GLA5PR GLARS-NF1 150–450 mg tablets were determined. Dove Medical Press 2018-10-11 /pmc/articles/PMC6187918/ /pubmed/30349198 http://dx.doi.org/10.2147/DDDT.S167668 Text en © 2018 Shin et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Original Research Shin, Kwang-Hee Jeon, Ji-Young Jang, Kyungho Kim, Tae-Eun Kim, Min-Gul Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study |
title | Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study |
title_full | Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study |
title_fullStr | Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study |
title_full_unstemmed | Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study |
title_short | Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study |
title_sort | dose-proportional pharmacokinetic properties of gla5pr glars-nf1 controlled-release pregabalin in healthy korean volunteers: a randomized, open, single-dose, parallel study |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6187918/ https://www.ncbi.nlm.nih.gov/pubmed/30349198 http://dx.doi.org/10.2147/DDDT.S167668 |
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