[Comparison study of two glimepiride formulations bioavailability in healthy volunteers of both sexes after a single dose administration]

[Comparison study of two glimepiride formulations bioavailability in healthy volunteers of both sexes after a single dose administration] Research Abstract Details 

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[Comparison study of two glimepiride formulations bioavailability in healthy volunteers of both sexes after a single dose administration] Abstract Text:

Ney Carter do Carmo Borges,Yara Del Antonio Taveira,Josimara A Mazucheli, Haddad,Rafael E B Astigarraga,Ronilson Agnaldo Moreno,

OBJECTIVE: To compare the bioavailability of two glimepiride 4-mg tablet formulation in 26 healthy volunteers of both sexes. MATERIAL AND 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. CONCLUSION: 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.

[Comparison study of two glimepiride formulations bioavailability in healthy volunteers of both sexes after a single dose administration] Publishing Authors By Initials

NC Borges,Ydel Taveira,JA Mazucheli,AL Haddad,RE Astigarraga,RA Moreno,

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[Comparison study of two glimepiride formulations bioavailability in healthy volunteers of both sexes after a single dose administration] Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Arquivos brasileiros de endocrinologia e metabolog

VOLUME: 51

Page Numbers: 950-5

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ISSN: 0004-2730

DAY: 15

MONTH: Aug

YEAR: 2007

[Comparison study of two glimepiride formulations bioavailability in healthy volunteers of both sexes after a single dose administration] Information

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LANGUAGE: por

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AFFILIATION: Synchrophar Assessoria e Desenvolvimento de Projetos Clínicos S/S.

Country: Brazil

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MEDLINETA: Arq Bras Endocrinol Metabol

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