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Bioequivalence evaluation of two brands of fluoxetine 20 mg capsules (Flutin and Prozac) in healthy human volunteers

โœ Scribed by Naji M. Najib; Nasir Idkaidek; Muntaser Beshtawi; B. Mohammed; Isra' Admour; S. Mahmood Alam; Ruwayda Dham; Qumaruzaman


Publisher
John Wiley and Sons
Year
2005
Tongue
English
Weight
79 KB
Volume
26
Category
Article
ISSN
0142-2782

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โœฆ Synopsis


A bioequivalence study of two oral formulations of 20 mg fluoxetine was carried out in 24 healthy volunteers following a single dose, two-sequence, crossover randomized design at International Pharmaceutical Research Centre (IPRC), Amman, Jordan. The two formulations were Flutin capsules (Julphar, UAE) as test and Prozac capsules (Eli Lilly, UK) as reference product. Test and reference capsules were administered to each subject after an overnight fasting on two treatment days separated by a 28 day washout period. After dosing, serial blood samples were collected for a period of 360 h. Plasma harvested from blood was analysed for fluoxetine by a sensitive, reproducible and accurate LC-MS method. Various pharmacokinetic parameters including AUC 0-t , AUC 0-/ , C max , T max , T 1/2 , and l Z were determined from plasma concentrations for both formulations and found to be in good agreement with reported values. AUC 0-t , AUC 0-/ and C max were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (94.60%-106.41% for AUC 0-t , 94.6%-108.14% for AUC 0-/ ; 91.88%-103.65% for C max ) for test/reference ratio of these parameters were found within FDA acceptance range of 80%-125%. Based on these statistical inferences, it was concluded that Flutin is bioequivalent to Prozac and can be used interchangeably in medical practice.


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