Comparative bioavailability of norfloxacin tablets based on blood and urine data.

Comparative bioavailability of norfloxacin tablets based on blood and urine data. Research Abstract Details 

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Comparative bioavailability of norfloxacin tablets based on blood and urine data. Abstract Text:

Aly H Nada,Mohamed A Sharaf,Zeinab A El Gholmy,Nawal M Khalafallah,Aly H Nada,Mohamed A Sharaf,Zeinab A El Gholmy,Nawal M Khalafallah,

OBJECTIVE: To assess the bioavailability of norfloxacin from urinary excretion relative to plasma concentration. MATERIALS AND METHODS: Twelve healthy volunteers (22-33 years) participated in the study. Each received a previously developed (M), a local (L) and a multinational (Noroxin) tablet (Ref), 400 mg each, according to a random balanced three-way crossover design on 3 different days. Blood samples were collected over a 12-hour period and urine over a 24-hour period. Norfloxacin concentrations were analyzed by a validated HPLC method. RESULTS: An initial estimate of bioequivalence of the three products was obtained using analysis of variance on transformed data and based on confidence interval calculation. Elimination pharmacokinetic parameters (half-life and renal clearance) calculated from plasma concentration and urinary excretion data (mean values, n = 36) were comparable to reported values for norfloxacin. Interproduct differences in elimination parameters (mean values, n = 12) were statistically insignificant (F values, ANOVA). Strong association was found between the mean of plasma concentration and urinary excretion rates for many volunteers (F values, regression analysis). Relative bioavailability values calculated for the local and previously developed products relative to Noroxin were higher than 85% based on area under the curve and urinary excretion. Bioequivalence could not be established among the three tested products based on calculated 90% confidence intervals. CONCLUSION: Urinary excretion of norfloxacin may be a useful noninvasive tool for bioavailability assessment of norfloxacin oral formulations.

Comparative bioavailability of norfloxacin tablets based on blood and urine data. Publishing Authors By Initials

AH Nada,MA Sharaf,ZA El Gholmy,NM Khalafallah,AH Nada,MA Sharaf,ZA El Gholmy,NM Khalafallah,

For similar pharmaceutical preparations: dosage forms: tablets research abstracts see: pharmaceutical preparations: dosage forms: tablets research

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Comparative bioavailability of norfloxacin tablets based on blood and urine data. Journal Published:

PUBLICATION TYPE: Randomized Controlled Trial

Journal: Medical principles and practice : international jo

VOLUME: 16

Page Numbers: 426-31

Journal Abbreviation:

ISSN: 1423-0151

DAY: 20

MONTH: 11

YEAR: 2007

Comparative bioavailability of norfloxacin tablets based on blood and urine data. Information

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LANGUAGE: eng

NlmUniqueID: 8901334

Comparative bioavailability of norfloxacin tablets based on blood and urine data. Keywords Mesh Terms:

KEYWORDS: Tablets

MESH TERMS: urine

Chemical & Substance for Abstract: Comparative bioavailability of norfloxacin tablets based on blood and urine data. Information

Substance Name: Norfloxacin

Registry Number: 70458-96-7

Grant and Affiliation Information for Comparative bioavailability of norfloxacin tablets based on blood and urine data.

AFFILIATION: Department of Pharmaceutics, Faculty of Pharmacy, Kuwait University, Kuwait. alynada@hsc.edu.kw

Country: Switzerland

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MEDLINETA: Med Princ Pract

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