title: Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects.
abstract: OBJECTIVE
  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 AUC(0-t), AUC(0-∞), 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 AUC(0-t), AUC(0-∞), and C(max) for rosuvastatin were 95.21% (87.56 - 103.53%), 95.76% (88.01 - 104.18%), and 99.33% (89.37 - 110.41%), respectively.
  
  
  CONCLUSIONS
  These results indicated that the two formulations of rosuvastatin were bioequivalent; therefore, they may be prescribed interchangeably.
authors.forename: Yahdiana
authors.initials: Y
authors.lastname: Harahap
authors.forename: Budi
authors.initials: B
authors.lastname: Prasaja
authors.forename: Fahmi
authors.initials: F
authors.lastname: Azmi
authors.forename: Windy
authors.initials: W
authors.lastname: Lusthom
authors.forename: Theresia
authors.initials: T
authors.lastname: Sinandang
authors.forename: Vita
authors.initials: V
authors.lastname: Felicia
authors.forename: Lia Yumi
authors.initials: LY
authors.lastname: Yusvita
authors.forename: Lianna Y
authors.initials: LY
authors.lastname: Panjaitan
mesh_terms: D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000493:pharmacokinetics*; D008297:Male; D000068718:Rosuvastatin Calcium / Q000493:pharmacokinetics*; D013607:Tablets; D013810:Therapeutic Equivalency
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D013607:Tablets; D000068718:Rosuvastatin Calcium