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Bioequivalence study of modified-release gliclazide tablets in healthy volunteers.
MedLine Citation:
PMID:  23029622     Owner:  NLM     Status:  PubMed-not-MEDLINE    
Abstract/OtherAbstract:
This study was aimed to investigate bioequivalence of modified-release 30 mg gliclazide tablets in 18 healthy Thai volunteers. A test product, Glycon MR (Siam Bheasach, TH), was compared with a reference product, Diamicron MR (Servier, France). The study was performed under a single-dose, two-treatment, two-period, and two-sequence crossover design in fasted and fed conditions with a washout period of 2 weeks. Blood samples were collected for 72 h after drug administration. Drug plasma concentrations were determined by HPLC with a UV detector. Analysis of pharmacokinetic characteristics was based on a non-compartmental model. The logarithmically transformed data of C(max) and AUCs were analyzed for 90% confidence intervals using ANOVA. The test product gave slightly higher C(max) in both conditions and shorter T(max) in the fed condition. However, there is no significant difference in pharmacokinetic characteristics between both products under fasted and fed conditions. Effect of food was not significantly observed. The 90% confidence intervals were within the acceptance criteria of 0.80-1.25 regardless of the food effect, indicating bioequivalence between the two products on the rate and extent of gliclazide MR absorption without regard to meals.
Authors:
Noppamas Rojanasthien; Thatree Autsavakitipong; Boonyium Kumsorn; Maleeya Manorot; Supanimit Teekachunhatean
Publication Detail:
Type:  Journal Article     Date:  2012-09-17
Journal Detail:
Title:  ISRN pharmacology     Volume:  2012     ISSN:  2090-5173     ISO Abbreviation:  ISRN Pharmacol     Publication Date:  2012  
Date Detail:
Created Date:  2012-10-02     Completed Date:  2012-10-02     Revised Date:  2013-02-27    
Medline Journal Info:
Nlm Unique ID:  101567048     Medline TA:  ISRN Pharmacol     Country:  Egypt    
Other Details:
Languages:  eng     Pagination:  375134     Citation Subset:  -    
Affiliation:
Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.
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