A bioequivalence study of quetiapine 25 mg film-coated tablets in healthy Indonesian subjects

作者：Harahap Yahdiana^*; Prasaja Budi; Lusthom Windy; Yusvita Lia Yumi; Sinandang Theresia; Hardiyanti

来源：International Journal of Clinical Pharmacology and Therapeutics, 2018, 56(1): 38-42.

DOI：10.5414/CP202975

• bioequivalence
• bioavailability
• film-coated
• pharmacokinetic
• quetiapine

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 AUC(0-t), AUC(0-infinity), and C-max. The 90% confidence intervals were obtained by analysis of variance for AUC(0-t), AUC(0-infinity), and C-max. 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.

• 出版日期2018-1