Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects

Yahdiana Harahap, Budi Prasaja, Fahmi Azmi, Windy Lusthom, Theresia Sinandang, Vita Felicia, Lia Yumi Yusvita, Lianna Y. Panjaitan

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Aim: To compare the bioavailability of two 40-mg Rosuvastatin tablet formulations. Methods: 24 subjects were included in this single-dose, open-label, randomized, two-way crossover study following an overnight fast. A 2-week wash out period was applied. Blood samples were drawn up to 72 hours following drug administrations. Rosuvastatin plasma concentrations were determined by liquid chromatography-tandem mass spectrometry method with TurboIon- Spray mode. Pharmacokinetic parameters AUC0-t, AUC0-∞;, and Cmax were determined and used for bioequivalence evaluation after log-transformation, whereas tmax ratios were evaluated nonparametrically. Results: The estimated point and 90% confidence intervals (CI) for AUC0-t, AUC0-∞, and Cmax for rosuvastatin were 95.21% (87.56 . 103.53%), 95.76% (88.01 . 104.18%), and 99.33% (89.37 . 110.41%), respectively. Conclusion: These results indicated that the two formulations of rosuvastatin were bioequivalent; therefore, they may be prescribed interchangeably.

Original languageEnglish
Pages (from-to)212-216
Number of pages5
JournalInternational Journal of Clinical Pharmacology and Therapeutics
Volume54
Issue number3
DOIs
Publication statusPublished - 1 Mar 2016

Keywords

  • Bioequivalence
  • HMG-CoA reductase inhibitor
  • LCMS/MS
  • Pharmacokinetic
  • Rosuvastatin

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