Bioequivalence study of generic gliclazide and Diamicron formulations in healthy Thai male volunteers.
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.
Rojanasthien
N
N
Division of Clinical Pharmacology, Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. nrojanas@med.cmu.ac.th
Sugunta
C
C
Rungapinan
S
S
Kumsorn
B
B
Sangdee
C
C
D000328:Adult; D000704:Analysis of Variance; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D016568:Drugs, Generic / Q000008:administration & dosage / Q000493:pharmacokinetics*; D005907:Gliclazide / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D006207:Half-Life; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D008875:Middle Aged; D012995:Solubility; D013607:Tablets
D016568:Drugs, Generic; D007004:Hypoglycemic Agents; D013607:Tablets; D005907:Gliclazide