Single and multiple dose bioequivalence evaluation of two brands of gliclazide modified release tablets in healthy Chinese male volunteers.
Randomized, two-way, crossover, single- and multiple-dose studies were conducted in healthy Chinese male volunteers to evaluate the bioequivalence of two brands of gliclazide (CAS 21187-98-4, 1-(3-azabicylco(3, 3, 0)oct-3-yl)-3-p-tolysulfonylurea) 30 mg tablets, viz. Gliclazide modified release (MR) tablets as test (T) and a commercial gliclazide standard preparation as reference (R) product. Each volunteer received T and R tablets separated by 7 days of a drug-free washout period. The plasma concentrations of gliclazide, determined by a validated LC-ESI-MS method, were employed to assess the pharmacokinetic parameters such as maximum and minimum observed plasma concentration (Cmax and Cmin), time to Cmax (tmax), average plasma concentration at steady state (Cav), area under plasma concentration curve (AUC(0-72), AUC(0-infinity) and AUC(ss), and degree of fluctuation for plasma concentration (DF %). As to these parameters, the analysis of variance (ANOVA) showed no significant difference and 90 % confidence intervals (CI) fell entirely into the acceptable range of bioequivalence. Based on these statistical inferences, the two formulations are considered bioequivalent in the extent and rate of absorption from both single- and multiple-dose studies.
Ling
Guixia
G
Department of Biopharmaceutics, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, The People's Republic of China.
Sun
Jin
J
Xu
Xiaodi
X
Sun
Yinghua
Y
He
Zhonggui
Z
D000328:Adult; D000704:Analysis of Variance; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D005907:Gliclazide / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D008297:Male; D012015:Reference Standards; D013810:Therapeutic Equivalency
D003692:Delayed-Action Preparations; D007004:Hypoglycemic Agents; D005907:Gliclazide