Bioequivalence study of 500 mg glucosamine sulfate in Thai healthy volunteers

Background and Objective: Glucosamine sulfate is widely used to relieve symptoms from osteoarthritis. The present study was conducted in order to determine pharmacokinetic and assess the in-vivo bioequivalence of two different hard capsule formulations of glucosamine sulfate when administered as equ...

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Main Authors: Pravit Akarasereenont, Somruedee Chatsiricharoenkul, Piyapat Pongnarin, Korbtham Sathirakul, Supornchai Kongpatanakul
Other Authors: Mahidol University
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Published: 2018
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Online Access:https://repository.li.mahidol.ac.th/handle/123456789/27952
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spelling th-mahidol.279522018-09-13T13:55:16Z Bioequivalence study of 500 mg glucosamine sulfate in Thai healthy volunteers Pravit Akarasereenont Somruedee Chatsiricharoenkul Piyapat Pongnarin Korbtham Sathirakul Supornchai Kongpatanakul Mahidol University Medicine Background and Objective: Glucosamine sulfate is widely used to relieve symptoms from osteoarthritis. The present study was conducted in order to determine pharmacokinetic and assess the in-vivo bioequivalence of two different hard capsule formulations of glucosamine sulfate when administered as equal dose of 500 mg. The two formulations contained different salt form where reference product is NaCl and test product is KCl. Material and Method: A randomized, single dose, two-treatment, two-period, two-sequence crossover study was conducted. Twenty-four healthy volunteers were recruited at Siriraj Clinical Research Unit. Each subject received a dose of 500 mg glucosamine sulfate of both formulations with at least one-week washout period. Blood samples were collected over 24 h after the oral administration. The plasma fractions were analyzed for glucosamine using a liquid chromatography-mass spectrometry (LC-MS/MS). Results: Twenty-four volunteers were enrolled in the present study. Pharmacokinetic parameters were determined using the non-compartment model. The 90% confidence intervals of the mean ratios (test/ reference) of Cmax (93.69%; ranged from 86.68%-113.32%) and AUC 0-t (97.73; ranged from 87.38%- 112.62%) fell within the acceptable range (80-125%) for bioequivalent eligibility. Both preparations were well tolerated and had a few non-serious adverse events. Conclusion: The glucosamine sulfate containing KCl (test product) is bioequivalent to glucosamine sulfate containing NaCl (reference product) in terms of rate and extent of absorption. 2018-09-13T06:55:16Z 2018-09-13T06:55:16Z 2009-09-01 Article Journal of the Medical Association of Thailand. Vol.92, No.9 (2009), 1234-1239 01252208 01252208 2-s2.0-70349266028 https://repository.li.mahidol.ac.th/handle/123456789/27952 Mahidol University SCOPUS https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=70349266028&origin=inward
institution Mahidol University
building Mahidol University Library
continent Asia
country Thailand
Thailand
content_provider Mahidol University Library
collection Mahidol University Institutional Repository
topic Medicine
spellingShingle Medicine
Pravit Akarasereenont
Somruedee Chatsiricharoenkul
Piyapat Pongnarin
Korbtham Sathirakul
Supornchai Kongpatanakul
Bioequivalence study of 500 mg glucosamine sulfate in Thai healthy volunteers
description Background and Objective: Glucosamine sulfate is widely used to relieve symptoms from osteoarthritis. The present study was conducted in order to determine pharmacokinetic and assess the in-vivo bioequivalence of two different hard capsule formulations of glucosamine sulfate when administered as equal dose of 500 mg. The two formulations contained different salt form where reference product is NaCl and test product is KCl. Material and Method: A randomized, single dose, two-treatment, two-period, two-sequence crossover study was conducted. Twenty-four healthy volunteers were recruited at Siriraj Clinical Research Unit. Each subject received a dose of 500 mg glucosamine sulfate of both formulations with at least one-week washout period. Blood samples were collected over 24 h after the oral administration. The plasma fractions were analyzed for glucosamine using a liquid chromatography-mass spectrometry (LC-MS/MS). Results: Twenty-four volunteers were enrolled in the present study. Pharmacokinetic parameters were determined using the non-compartment model. The 90% confidence intervals of the mean ratios (test/ reference) of Cmax (93.69%; ranged from 86.68%-113.32%) and AUC 0-t (97.73; ranged from 87.38%- 112.62%) fell within the acceptable range (80-125%) for bioequivalent eligibility. Both preparations were well tolerated and had a few non-serious adverse events. Conclusion: The glucosamine sulfate containing KCl (test product) is bioequivalent to glucosamine sulfate containing NaCl (reference product) in terms of rate and extent of absorption.
author2 Mahidol University
author_facet Mahidol University
Pravit Akarasereenont
Somruedee Chatsiricharoenkul
Piyapat Pongnarin
Korbtham Sathirakul
Supornchai Kongpatanakul
format Article
author Pravit Akarasereenont
Somruedee Chatsiricharoenkul
Piyapat Pongnarin
Korbtham Sathirakul
Supornchai Kongpatanakul
author_sort Pravit Akarasereenont
title Bioequivalence study of 500 mg glucosamine sulfate in Thai healthy volunteers
title_short Bioequivalence study of 500 mg glucosamine sulfate in Thai healthy volunteers
title_full Bioequivalence study of 500 mg glucosamine sulfate in Thai healthy volunteers
title_fullStr Bioequivalence study of 500 mg glucosamine sulfate in Thai healthy volunteers
title_full_unstemmed Bioequivalence study of 500 mg glucosamine sulfate in Thai healthy volunteers
title_sort bioequivalence study of 500 mg glucosamine sulfate in thai healthy volunteers
publishDate 2018
url https://repository.li.mahidol.ac.th/handle/123456789/27952
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