Bioequivalence Study of 500 mg Glucosamine Sulfate in Thai Healthy Volunteers
Pravit Akarasereenont MD, PhD*, Somruedee Chatsiricharoenkul MD*, Piyapat Pongnarin MSc*, Korbtham Sathirakul PhD**, Supornchai Kongpatanakul MD*
Affiliation : * Department of Pharmacology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand ** Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand
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 AUC0-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.
Keywords : Bioequivalence, Liquid chromatography-mass spectrometry, Glucosamine, Pharmacokinetics
