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

Yahdiana Harahap, Budi Prasaja, Windy Lusthom, Lia Yumi Yusvita, Theresia Sinandang, Hardiyanti

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)38-42
Number of pages5
JournalInternational Journal of Clinical Pharmacology and Therapeutics
Volume56
Issue number1
DOIs
Publication statusPublished - 1 Jan 2018

Keywords

  • Bioavailability
  • Bioequivalence
  • Filmcoated
  • Pharmacokinetic
  • Quetiapine

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