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Suchschritt : FT=glucosamine AND FT=osteoarthritis
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2/83 von 416 DIMDI: MEDLINE (ME60) © NLM

ND: | ME16168682
PMID: | 16168682
LR: | 20061115
CED: | 20051128
DCO: | 20060522
Autoren: | Persiani S; Roda E; Rovati LC; Locatelli M; Giacovelli G; Roda A
Titel: | Glucosamine oral bioavailability and plasma pharmacokinetics after increasing doses of crystalline glucosamine sulfate in man.
Quelle: | Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society; VOL: 13 (12); p. 1041-9 /200512/
PM: | Print-Electronic
EPD: | 20050913
SU: | IM
Sprache: | English
CY: | England
JID: | 9305697
ISSN: | 1063-4584
Institution: | Clinical Pharmacology Department, Rotta Research Laboratorium/Rottapharm, Monza, Italy. stefano.persiani@rotta.com
DT: | Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Schlagwörter
CT: | ADMINISTRATION, ORAL; ADULT; ANALYSIS OF VARIANCE; BIOLOGICAL AVAILABILITY; CHROMATOGRAPHY, LIQUID; CROSS-OVER STUDIES; CRYSTALLIZATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLUCOSAMINE/blood; GLUCOSAMINE/*pharmacokinetics; HALF-LIFE; HUMANS; MALE; SPECTRUM ANALYSIS
CTG: | APPLIKATION, ORALE; ERWACHSENER; VARIANZANALYSE; BIOLOGISCHE VERFÜGBARKEIT; CHROMATOGRAPHIE, FLÜSSIGKEITS-; CROSS-OVER-STUDIEN; KRISTALLISATION; DOSIS-WIRKUNGSBEZIEHUNG, ARZNEIMITTEL-; ARZNEIMITTELAPPLIKATIONSPLAN; WEIBLICH; GLUCOSAMIN/Blut; GLUCOSAMIN/*Pharmakokinetik; HALBWERTZEIT; MENSCH; MÄNNLICH; SPEKTRALANALYSE
TE: | Glucosamine/3416-24-8
CR: | 3416-24-8
AB: | OBJECTIVE: Pharmacokinetic data on glucosamine are scant, limiting the understanding of glucosamine sulfate mechanism of action in support of its treatment effects in osteoarthritis. This study investigated the oral pharmacokinetics and dose-proportionality of glucosamine after administration of the patented crystalline glucosamine sulfate in man. METHODS: Twelve healthy volunteers received three consecutive once-daily oral administrations of glucosamine sulfate soluble powder at the doses of 750, 1,500, and 3,000 mg, in an open, randomised, cross-over fashion. Glucosamine was determined in plasma collected up to 48 h after the last dose by a validated Liquid Chromatography method with Mass Spectrometry detection. Pharmacokinetic parameters were calculated at steady state. RESULTS: Endogenous plasma levels of glucosamine were detected (10.4-204 ng/ml, with low intra-subject variability). Glucosamine was rapidly absorbed after oral administration and its pharmacokinetics were linear in the dose range 750-1,500 mg, but not at 3,000 mg, where the plasma concentration-time profiles were less than expected based on dose-proportionality. Plasma levels increased over 30-folds from baseline and peaked at about 10 microM with the standard 1,500 mg once-daily dosage. Glucosamine distributed to extravascular compartments and its plasma concentrations were still above baseline up to the last collection time. Glucosamine elimination half-life was only tentatively estimated to average 15 h. CONCLUSIONS: Glucosamine is bioavailable after oral administration of crystalline glucosamine sulfate, persists in circulation, and its pharmacokinetics support once-daily dosage. Steady state peak concentrations at the therapeutic dose of 1,500 mg were in line with those found to be effective in selected in vitro mechanistic studies. This is the only glucosamine formulation for which pharmacokinetic, efficacy and safety data are now available.

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