Bioequivalence Test of the Generic Gliclazide (Dianid®) and the Innovator (Diamicron®) in Healthy Thai Male Volunteers
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Abstract
The purpose of this study was to compare the bioequivalence of 80 mg oral
hypoglycemic gliclazide preparations between a generic (Dianid® The Biolab
Company, Thailand), and the inovator (Diamicron ® Les laboratories, Servier
Industrie, France). The pharmacokinetics and bioequivalence test were studied in 12
healthy male subjects. A single oral dose of each preparation was given to the
subjects in a randomized double-blind, two period crossover design with 2 weeks
washout period. Blood samples were collected before and at 1, 3, 5, 6, 7, 8, 9, 10, 11,
12, 13, 15, 24, 30, 36, 48, 60 hours after drug administration. Serum gliclazide
concentrations were determined by using high - performance liquid chromatography.
Individual concentration time profiles were depicted and the pharmacokinetic
parameters were analyzed by noncompartmental pharmacokinetic method with the
use of TOPFIT, a pharmacokinetic data analysis program. Statistical analysis
comparing the parameters between the test and reference preparations was performed
by three-way ANOV A. No significant differences in area under the serum
concentration-time curves at time 0 to infinity (AUC0-∞), maximal gliclazide
concentrations (Cmax) and time to the Cmax (Tmax) were observed between the test
and reference preparations. The means and 90% confidence intervals (90% CI) of the
Dianid®/Diamicron® ratios of AUC0-∞ and the Cmax were 1.08 (0.98-1.18) and 1.09
(0.89-1.34), respectively. These values were well within the acceptable
bioequivalence ranges of 0.8-1.25 proposed by the United States Food and Drug
Administration (USFDA) and 0.70-1.43 proposed by the commission of the European
Community of Food and Drug Administration (ECFDA), respectively. The means and
90% CI of the difference in Tmax between Dianid® and Diamicron® were 0.08 [(-1.44) -1.61] hour. This value was within the stipulated bioequivalence range of ± 2.30hours
(± 20 % of the Tmax of the reference formulation). Thus, the test product Dianid®
was considered bioequivalent to the reference Diamicron® regarding the rate
of absorption (Cmax and Tmax) and the extent of absorption (AUC).
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