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Bioavailability of fluvoxamine given with and without food
J Van Harten1, P Van Bemmel, M R Dobrinska
1Department of Drug Disposition, Weesp, The Netherlands.
Biopharmaceutics & Drug Disposition
|November 1, 1991
Summary
Food intake has a negligible effect on fluvoxamine maleate plasma concentrations. This study found no significant impact on maximum drug levels or absorption time, supporting consistent efficacy.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Drug Metabolism
Background:
- Fluvoxamine maleate is a widely prescribed antidepressant.
- Understanding drug-food interactions is crucial for optimizing therapeutic outcomes.
- Previous pharmacokinetic data for fluvoxamine maleate in fed versus fasted states is limited.
Purpose of the Study:
- To investigate the influence of concomitant food intake on the plasma concentrations of fluvoxamine maleate.
- To determine the pharmacokinetic profile of fluvoxamine maleate when administered with and without food.
Main Methods:
- A two-way, crossover study design was employed.
- Twelve healthy young volunteers (8 male, 4 female) received a single 50 mg oral dose of fluvoxamine maleate.
- Plasma drug concentrations were measured after administration in both fasted and fed (post-breakfast) states.
Main Results:
- Concomitant food intake did not significantly alter the maximum plasma fluvoxamine concentrations (Cmax).
- The time to reach maximum plasma concentrations (tmax) was unaffected by food.
- Area under the plasma concentration-time curve (AUC) was approximately 7% lower in the fed state compared to the fasted state.
Conclusions:
- The pharmacokinetic impact of food on fluvoxamine maleate is considered negligible.
- This suggests that fluvoxamine maleate can be administered with or without food without compromising its overall exposure.
- Clinicians can be assured of consistent drug absorption regardless of meal timing.