PMID- 19695404
OWN - NLM
STAT- MEDLINE
DCOM- 20091028
LR  - 20221207
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 31
IP  - 7
DP  - 2009 Jul
TI  - 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.
PG  - 1551-8
LID - 10.1016/j.clinthera.2009.07.019 [doi]
AB  - BACKGROUND: Glucosamine sulfate is used for the treatment of arthrosis, 
      especially osteoarthritis of the knee joint. The available evidence suggests 
      differences in its pharmacokinetics in Chinese subjects compared with non-Chinese 
      subjects. OBJECTIVE: The aim of this study was to compare the pharmacokinetics 
      and relative bioavailability of a test and reference formulation of glucosamine 
      sulfate 500 mg after single oral administration in healthy Chinese volunteers. 
      METHODS: This open-label, randomized-sequence, single-dose, 2-way crossover study 
      was performed at the First Hospital of Nanjing Medical University, Nanjing, 
      China. Eligible subjects were healthy male volunteers who were randomly assigned 
      at a 1:1 ratio to receive a single 500-mg dose of the test or reference capsule 
      formulation, followed by a 1-week washout period and administration of the 
      alternate formulation. The study drugs were administered after a 12-hour 
      overnight fast. Glucosamine sulfate was assayed using a liquid-chromatography 
      tandem mass spectrometry method. For analysis of pharmacokinetic properties, 
      including C(max), AUC(0-t), and AUC(0-infinity)), blood samples were obtained at 
      intervals over a 14-hour period after study drug administration. The formulations 
      were considered bioequivalent if the log-transformed ratios of C(max) and AUC 
      were within the predetermined equivalence range (70%-143% for C(max) and 80%-125% 
      for AUC) as established by the State Food and Drug Administration (SFDA) of 
      China. Tolerability was assessed by monitoring vital signs and laboratory tests 
      (hematology, blood biochemistry, hepatic function, and urinalysis), and by 
      questioning subjects about adverse events (AEs). RESULTS: Twenty-two healthy male 
      Chinese subjects were enrolled (mean [range] age, 24 [22-26] years; weight, 63.9 
      [58.5-69.3] kg; height, 172 [167-177] cm); all completed the study. No period or 
      sequence effect was observed. The 90% CIs for the log-transformed ratios of 
      C(max), AUC(0-t), and AUC(0-infinity)) were 93.4 to 127.3, 92.4 to 114.5, and 
      92.7 to 114.6, respectively (all, P = NS). The AUC(0-infinity) of the test and 
      reference formulations was 1.83 (0.66) and 1.77 ( 0.72) microg/h/mL, 
      respectively. No AEs were observed or reported during the study. CONCLUSIONS: In 
      this small study in healthy male Chinese volunteers, a single 500-mg dose of the 
      test formulation met the SFDA's regulatory definition for bioequivalence to the 
      reference formulation. Both formulations were well tolerated.
FAU - Zhu, YuBing
AU  - Zhu Y
AD  - Department of Clinical Pharmacology, First Hospital of Nanjing Medical 
      University, Nanjing 210006, China.
FAU - Zou, JianJun
AU  - Zou J
FAU - Xiao, DaWei
AU  - Xiao D
FAU - Fan, HongWei
AU  - Fan H
FAU - Yu, CuiXia
AU  - Yu C
FAU - Zhang, JingJing
AU  - Zhang J
FAU - Yang, Jing
AU  - Yang J
FAU - Guo, DaQing
AU  - Guo D
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Capsules)
RN  - N08U5BOQ1K (Glucosamine)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Area Under Curve
MH  - Asian People
MH  - Biological Availability
MH  - Capsules
MH  - China
MH  - Chromatography, Liquid
MH  - Cross-Over Studies
MH  - Glucosamine/administration & dosage/adverse effects/*pharmacokinetics
MH  - Humans
MH  - Male
MH  - Tandem Mass Spectrometry
MH  - Therapeutic Equivalency
MH  - Young Adult
EDAT- 2009/08/22 09:00
MHDA- 2009/10/29 06:00
CRDT- 2009/08/22 09:00
PHST- 2009/05/20 00:00 [accepted]
PHST- 2009/08/22 09:00 [entrez]
PHST- 2009/08/22 09:00 [pubmed]
PHST- 2009/10/29 06:00 [medline]
AID - S0149-2918(09)00232-X [pii]
AID - 10.1016/j.clinthera.2009.07.019 [doi]
PST - ppublish
SO  - Clin Ther. 2009 Jul;31(7):1551-8. doi: 10.1016/j.clinthera.2009.07.019.