Aim: This study was conducted in order to compare the bioavailability of two film-coated tablets containing 25 mg of quetiapine.
Methods: 24 subjects were enrolled in and completed a single-center, randomized, single-dose, open-label, two-way crossover study with a 1-week washout period. Plasma samples were collected up to 24 hours following drug administration; thus, quetiapine was determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) method with turbo-ion-spray mode. The pharmacokinetic parameters used for bioequivalence assessment were AUC0-t, AUC0-∞, and Cmax. The 90% confidence intervals were obtained by analysis of variance for AUC0-t, AUC0-∞, and Cmax.
Results: The results were all within the range of 80.00 - 125.00%.
Conclusion: Bioequivalence between formulations was concluded both in terms of rate and extent of absorption. .