[Comparison study of two glimepiride formulations bioavailability in healthy volunteers of both sexes after a single dose administration].
OBJECTIVE
To compare the bioavailability of two glimepiride 4-mg tablet formulation in 26 healthy volunteers of both sexes.


METHODS
The study was conducted open with randomized two-period crossover design and a 14-day washout period. Samples were obtained over a 48-hour interval. Glimepiride concentrations were analyzed by LC-MS-MS. From the glimepiride plasma concentration versus time curves the following pharmacokinetic parameters were obtained: AUC(0-last), AUC(0-t), AUC(0-infinity), Ke, T1/2, Cmax, and Tmax.


RESULTS
Geometric mean of Glimepirida/Amaryl 4 mg was 102.35% for AUC(0-t), 102.35% for AUC(0-infinity) and 99.31% for Cmax. The 90% CI was 92.62-109.55%; 95.62-109.55% e 88.60-111.32%, respectively.


CONCLUSIONS
Since the 90% CI for both Cmax, AUC(0-t), and AUC(0-infinity) were within the interval of 80-125%, it was concluded that both formulations were bioequivalent, according to both the rate and extent of absorption.
Borges
Ney Carter do Carmo
NC
Synchrophar Assessoria e Desenvolvimento de Projetos Clínicos S/S.
Taveira
Yara Del Antonio
Ydel A
Mazucheli
Josimara A
JA
Haddad
André Luiz
AL
Astigarraga
Rafael E B
RE
Moreno
Ronilson Agnaldo
RA
D000328:Adult; D001682:Biological Availability; D002214:Capsules; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D012016:Reference Values; D013453:Sulfonylurea Compounds / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D002214:Capsules; D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; C057619:glimepiride