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Bioequivalence Study of Modified-Release Gliclazide Tablets in Healthy Volunteers
Joint Authors
Autsavakitipong, Thatree
Kumsorn, Boonyium
Rojanasthien, Noppamas
Teekachunhatean, Supanimit
Manorot, Maleeya
Source
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-6, 6 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2012-09-17
Country of Publication
Egypt
No. of Pages
6
Main Subjects
Pharmacy, Health & Medical Sciences
Pharmacology
Abstract EN
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 Cmax and AUCs were analyzed for 90% confidence intervals using ANOVA.
The test product gave slightly higher Cmax in both conditions and shorter Tmax 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.
American Psychological Association (APA)
Rojanasthien, Noppamas& Autsavakitipong, Thatree& Kumsorn, Boonyium& Manorot, Maleeya& Teekachunhatean, Supanimit. 2012. Bioequivalence Study of Modified-Release Gliclazide Tablets in Healthy Volunteers. ISRN Pharmacology،Vol. 2012, no. 2012, pp.1-6.
https://search.emarefa.net/detail/BIM-467103
Modern Language Association (MLA)
Rojanasthien, Noppamas…[et al.]. Bioequivalence Study of Modified-Release Gliclazide Tablets in Healthy Volunteers. ISRN Pharmacology No. 2012 (2012), pp.1-6.
https://search.emarefa.net/detail/BIM-467103
American Medical Association (AMA)
Rojanasthien, Noppamas& Autsavakitipong, Thatree& Kumsorn, Boonyium& Manorot, Maleeya& Teekachunhatean, Supanimit. Bioequivalence Study of Modified-Release Gliclazide Tablets in Healthy Volunteers. ISRN Pharmacology. 2012. Vol. 2012, no. 2012, pp.1-6.
https://search.emarefa.net/detail/BIM-467103
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-467103