2–3 Jun 2022 مؤتمر
كلية الصيدلة
Asia/Baghdad timezone

Effect of food on the pharmacokinetics of fluoxetine administered to healthy male adult volunteers

Not scheduled
20m
كلية الصيدلة

كلية الصيدلة

Live presentation Conference Track Four

Speaker

Dr duaa Al-Tamimi

Description

Fluoxetine (FX) is an antidepressant drug administered only orally in humans. Despite the wide use of FX, until now, there is only limited literature concerning the pharmacokinetics (PK) of FX and the effect of food on its PK. Thus, the objective of this investigation was to study the PK of FX in Arabic healthy male adult volunteers under fasting and fed conditions. In the fasting study, FX 20 mg capsules (Prozac®, Eli Lilly, Canada) were administered to 41 volunteers after overnight fasting of 12 hours, followed by blood sampling from each volunteer immediately before dosing (zero time) and then at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 60, 72, 96, 120, and eventually at 144 hours after FX dosing. The fed study was conducted after 90 days wash-out period following the completion of the fasting study. The same subjects who received FX in the fasting study were administered the drug directly after a fatty breakfast (fed study), followed by blood sampling intervals similar to the schedule mentioned above for the fasting study. The current investigation demonstrated no statistical differences in the FX pharmacokinetic parameters Cmax, AUC0–t, AUC0–∞, Kel, T1/2, MRT, Cl/F, and Vd/F after fasting compared to the fed conditions, whereas there was statistically significant elongation in the Tmax values after food intake. Therefore, this study concludes the absence of food effect on the PK of FX (except Tmax) in the Arabic population and confirms the method of administration mentioned in the product information but also concludes high interindividual variation in FX exposure (AUC), which suggest that therapeutic drug monitoring (TDM) might be advisable when feasible.

Field/discipline Pharmaceutics
Has the manuscript been published? Not published
Intend to be published in the conference journal (IJPS)? Yes

Primary authors

Dr duaa Al-Tamimi Dr Khalid Al-Kinani (2Department of Pharmaceutics, College of Pharmacy, University of Baghdad, Ministry of Higher Education and Scientific Research, Baghdad, Iraq. ) Dr Salam Taher (3Department of Pharmaceutics, College of Pharmacy, University of Baghdad, Ministry of Higher Education and Scientific Research, Baghdad, Iraq. ) Ahmed Hussein (4Department of Pharmacy, Baghdad College of Medical Sciences, Ministry of Higher Education and Scientific Research, Baghdad, Iraq.)

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