Investigation of Pharmacokinetics and Bioequivalence of Mecobalamin in Healthy Volunteers by Chemilu-minescent Microparticle Immunoassay / 中国药师
China Pharmacist
;
(12): 1619-1621,1622, 2014.
Article
in Chinese
| WPRIM
| ID: wpr-602083
ABSTRACT
Objective:
To develop a chemiluminescent microparticle immunoassay ( CMIA) method for the determination of meco-balamin in human serum to investigate the pharmacokinetics and bioequivalence of mecobalamin.Methods:
A single oral dose of two kinds of mecobalamin was given to 19 healthy volunteers in a randomized three-period crossover study. The concentrations of mecobal-amin in serum were assayed by CMIA, the main pharmacokinetic parameters were analyzed by DAS 3. 0 software, and the bioequiva-lence was evaluated.Results:
The main pharmacokinetic parameters of test and reference mecobalamin tablets were as follows tmax were (4.2 ±1.9)h and (4.4 ±2.4)h,Cmax were (322.0 ±145.4) ng·L-1 and (282.2 ±108.1) ng·L-1,t1/2 were (19.2 ±5.3) h and (20.0 ±6.3)h,AUC0-72 were (6 769.1 ±2 169.4) ng·h·L-1 and (6 400.6 ±1 921.5) ng·h·L-1. F(0-72) and F(0-∞) of the test tablets was 105. 9% ± 13. 2% and 104. 9% ± 12. 6%,respectively.Conclusion:
The method is simple and precise. The two tablets are bioequivalent.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Controlled clinical trial
Language:
Chinese
Journal:
China Pharmacist
Year:
2014
Type:
Article
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