Bioequivalence evaluation of two brands of fluoxetine 20 mg capsules (Flutin and Prozac) in healthy human volunteers.
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-infinity), C(max), T(max), T(1/2), and lambda(Z) were determined from plasma concentrations for both formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0-infinity) 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-infinity); 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.
Najib
Naji M
NM
International Pharmaceutical Research Centre (IPRC), Amman, Jordan.
Idkaidek
Nasir
N
Beshtawi
Muntaser
M
Mohammed
B
B
Admour
Isra
I
Alam
S Mahmood
SM
Dham
Ruwayda
R
Qumaruzaman
D000328:Adult; D019540:Area Under Curve; D002214:Capsules; D018592:Cross-Over Studies; D005473:Fluoxetine / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D017367:Selective Serotonin Reuptake Inhibitors / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D002214:Capsules; D005473:Fluoxetine; D017367:Selective Serotonin Reuptake Inhibitors