title: Comparative bioavailability of two estazolam tablet formulations in Indonesian healthy volunteers.
abstract: OBJECTIVE
  To compare the bioavailability of two estazolam (CAS 29975-16-4) tablet formulations (Estalin 2 mg tablets as test formulation and 2 mg tablets of the originator product as reference formulation).
  
  
  METHODS
  The study was conducted according to an open label, randomized two-way cross-over design with a two-week washout period. Twenty-four subjects received each of the two estazolam formulations. Blood samples for pharmacokinetic profiling were taken up to 72 h after drug administration in fasting condition. Plasma concentrations of estazolam were determined with a validated HPLC method with ultraviolet detection. Pharmacokinetic parameters were calculated from observed plasma concentration-time profiles.
  
  
  RESULTS
  The mean AUC(0-t), AUC(0-infinity) and Cmax were 2581.38 ng x h/mL, 2934.37 ng x h/mL and 95.25 ng/mL, respectively for the test formulation and 2835.75 ng x h/ mL, 3207.73 ng x h/mL and 99.32 ng/mL, respectively, for the reference formulation. The median Tmax for both formulations was 1 h. The point estimates and 90% confidence Intervals for AUC(0-t), AUC(0-infinity) and Cmax were 91.03% (87.48-94.72%), 91.48% (86.67-96.55%) and 95.90% (92.60-99.31%) respectively, satisfying the bloequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration guidelines.
  
  
  CONCLUSIONS
  These results indicate that two formulations of estazolam are bioequivalent and, thus, may be prescribed interchangeably.
authors.affiliation: Department of Pharmacy, Faculty of Mathematic and Science, University of Indonesia, Depok, Indonesia.
authors.forename: Yahdiana
authors.initials: Y
authors.lastname: Harahap
authors.forename: Lucy
authors.initials: L
authors.lastname: Sasongko
authors.forename: Budi
authors.initials: B
authors.lastname: Prasaja
authors.forename: Ega
authors.initials: E
authors.lastname: Indriati
authors.forename: Windy
authors.initials: W
authors.lastname: Lusthom
authors.lastname: Lipin
mesh_terms: D000293:Adolescent; D000328:Adult; D014151:Anti-Anxiety Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004949:Estazolam / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D007214:Indonesia; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D014151:Anti-Anxiety Agents; D013607:Tablets; D004949:Estazolam