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Int J Clin Pharmacol Ther. 2003 Jul;41(7):323-30.

Bioequivalence study of generic gliclazide and Diamicron formulations in healthy Thai male volunteers.

Author information

  • 1Division of Clinical Pharmacology, Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. nrojanas@med.cmu.ac.th

Abstract

The objective of this study was to compare the bioequivalence of 80 mg gliclazide in healthy Thai males. A single dose of each preparation was administered after an overnight fast in a 2-period crossover design with a 2-week washout period. Serial blood samples were collected over a period of 60 hours. Plasma gliclazide concentrations were determined using HPLC and the pharmacokinetic parameters were analyzed by non-compartmental analysis.

RESULTS:

The median time to reach the maximal concentration (Tmax) for the test formulation was identical to that of the reference Diamicron (11.5 h). Similarly, the mean elimination half-lives (t1/2) for the test (20.4 +/- 7.8 h) and Diamicron (21.5 +/- 9.4 h) were comparable. Analysis of variance was carried out using logarithmic transformations of AUC(0-infinity) and Cmax as well as non-transformed Tmax. The mean (90% CI) of the difference in Tmax (h) was 0.08 ((-1.44)-1.61). The mean (90% CI) of the AUC(0-infinity) and Cmax ratios for (test/reference) were 1.08 (0.98-1.18) and 1.09 (0.89-1.34), respectively. Since these values fall within the bioequivalence criteria, our study demonstrates bioequivalence of the 2 products.

PMID:
12875349
[PubMed - indexed for MEDLINE]
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