Bioequivalence of two formulations of glucosamine sulfate 500-mg capsules in healthy male chinese volunteers: An open-label, randomized-sequence, single-dose, fasting, two-way crossover study

Clinical Therapeutics

Volumn 31, Issue 7, 2009, Pages 1551-1558

  Zhu, YuBing ^a   Zou, JianJun ^a   Xiao, DaWei ^a   Fan, HongWei ^a   Yu, CuiXia ^a   Zhang, JingJing ^a   Yang, Jing ^a   Guo, DaQing ^b  

^a NANJING MEDICAL UNIVERSITY   (China)

^b CENTRAL SOUTH UNIVERSITY   (China)

Author keywords

bioequivalence; glucosamine sulfate capsules; LC MS MS; pharmacokinetics

Indexed keywords

GLUCOSAMINE SULFATE;

ABSENCE OF SIDE EFFECTS; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CHINESE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG FORMULATION; DRUG TOLERABILITY; HALF LIFE TIME; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OPEN STUDY; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADMINISTRATION, ORAL; ADULT; AREA UNDER CURVE; ASIAN CONTINENTAL ANCESTRY GROUP; BIOLOGICAL AVAILABILITY; CAPSULES; CHINA; CHROMATOGRAPHY, LIQUID; CROSS-OVER STUDIES; GLUCOSAMINE; HUMANS; MALE; TANDEM MASS SPECTROMETRY; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 68649121664     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.07.019     Document Type: Article

References (14)

1. Ilic M.Z., Martinac B., Samiric T., and Handley C.J. Effects of glucosamine on proteoglycan loss by tendon, ligament and joint capsule explant cultures. Osteoarthritis Cartilage. 16 (2008) 1501-1508
2. Richy F., Bruyere O., Ethgen O., et al. Structural and symptomatic efficacy of glucosamine and chondroitin in knee osteoarthritis: A comprehensive meta-analysis. Arch Intern Med. 163 (2003) 1514-1522
3. Vangsness Jr. C.T., Spiker J.W., and Erickson J. A review of evidence-based medicine for glucosamine and chondroi-tin sulfate use in knee osteoarthritis. Arthroscopy. 25 (2009) 86-94
4. Reginster J.Y., Deroisy R., Rovati L.C., et al. Long-term effects of glucosamine sulphate on osteoarthritis progression: A randomised, placebo-controlled clinical trial. Lancet. 357 (2001) 251-256
5. Pavelká K., Gatterová J., Olejarová M., et al. Glucosamine sulfate use and delay of progression of knee osteoarthritis: A 3-year, randomized, placebo-controlled, doubleblind study. Arch Intern Med. 162 (2002) 2113-2123
6. Poolsup N., Suthisisang C., Channark P., and Kittikulsuth W. Glucosamine long-term treatment and the progression of knee osteoarthritis: Systematic review of randomized controlled trials. Ann Pharmacother. 39 (2005) 1080-1087
7. Sawitzke A.D., Shi H., Finco M.F., et al. The effect of glucosamine and/or chondroitin sulfate on the progression of knee osteoarthritis: A report from the glucosamine/ chondroitin arthritis intervention trial. Arthritis Rheum. 58 (2008) 3183-3191
8. Persiani S., Roda E., Rovati L.C., et al. Glucosamine oral bioavailability and plasma pharmacokinetics after increasing doses of crystalline glucosamine sulfate in man. Osteoarthritis Cartilage. 13 (2005) 1041-1049
9. Persiani S., Rotini R., Trisolino G., et al. Synovial and plasma glucosamine concentrations in osteoarthritic patients following oral crystalline glucosamine sulphate at therapeutic dose. Osteoarthritis Cartilage. 15 (2007) 764-772
10. Zhang L.J., Huang T.M., Fang X.L., et al. Determination of glucosamine sulfate in human plasma by precolumn de-rivatization using high performance liquid chromatog-raphy with fluorescence detection: Its application to a bioequivalence study. J Chromatogr B Analyt Technol Biomed Life Sci. 842 (2006) 8-12
11. Zhong S., Zhong D., and Chen X. Improved and simplified liquid chromatography/electrospray ionization mass spec-trometry method for the analysis of underivatized glu-cosamine in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 854 (2007) 291-298
12. Center for Drug Evaluation and Research, and US Food and Drug Administration. Guidance for industry. Bioanalytical method validation. http://www.fda.gov/cder/guidance/4252fnl.htm Accessed March 3, 2009
13. Center for Drug Evaluation and Research, and US Food and Drug Administration. Guidance for industry. Human drugs in vivo bioequivalence compliance program 7348.001. http://www.fda.gov/ora/compliance_ref/bimo/7348_001/default.htm Accessed March 3, 2009
14. Chow S.C., and Liu J.P. Design and Analysis of Bioavailability and Bioequivalence Studies. 3rd ed (2008), Marcel Dekker, New York, NY