Bioequivalence Test of the Generic Gliclazide (Dianid®) and the Innovator (Diamicron®) in Healthy Thai Male Volunteers

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Chiraporn Sugunta
Noppamas Rojanasthien
Sukit Rung-Apinan
Chaichan Sangdee
Boonyium Kumsorn

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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Section
2002 Annual Meeting Abstracts/Lectures

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