Akarasereenont Pravit, Chatsiricharoenkul Somruedee, Pongnarin Piyapat, Sathirakul Korbtham, Kongpatanakul Supornchai
Department of Pharmacology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
J Med Assoc Thai. 2009 Sep;92(9):1234-9.
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.
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).
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 C(max) (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.
The glucosamine sulfate containing KCl (test product) is bioequivalent to glucosamine sulfate containing NaCl (reference product) in terms of rate and extent of absorption.
硫酸氨基葡萄糖被广泛用于缓解骨关节炎症状。本研究旨在确定硫酸氨基葡萄糖两种不同硬胶囊制剂在给予500毫克等效剂量时的药代动力学并评估其体内生物等效性。两种制剂含有不同的盐形式，参比产品为氯化钠，受试产品为氯化钾。
进行了一项随机、单剂量、双治疗、双周期、双序列交叉研究。在诗里拉吉临床研究单位招募了24名健康志愿者。每位受试者接受两种制剂各500毫克硫酸氨基葡萄糖的剂量，洗脱期至少为一周。口服给药后24小时内采集血样。使用液相色谱 - 质谱联用仪（LC-MS/MS）分析血浆组分中的氨基葡萄糖。
本研究纳入了24名志愿者。使用非房室模型确定药代动力学参数。C(max)（93.69%；范围为86.68% - 113.32%）和AUC(0 - t)（97.73；范围为87.38% - 112.62%）的平均比值（受试/参比）的90%置信区间落在生物等效性合格的可接受范围内（80% - 125%）。两种制剂耐受性良好，仅有少数非严重不良事件。
含氯化钾的硫酸氨基葡萄糖（受试产品）在吸收速率和程度方面与含氯化钠的硫酸氨基葡萄糖（参比产品）生物等效。
