title: Comparative bioavailability of two dexamethasone tablet formulations in Indonesian healthy volunteers.
abstract: OBJECTIVE
  To compare the bioavailability of two dexamethasone (CAS 50-02-2) tablet formulations -- 4 mg Dexmethsone tablets as test formulation and 4 mg tablets of the originator product as reference formulation.
  
  
  METHODS
  The study was conducted according to an open-label, randomized two-way crossover design with a one-week washout period. Twenty-four volunteers received a single dose of two tablets of the two different dexamethasone formulations. Blood samples for pharmacokinetic profiling were taken up to 24 h after drug administration in fasting condition. Plasma concentrations of dexamethasone were determined with a validated HPLC method using an ultraviolet detector. Pharmacokinetic parameters were calculated from observed plasma concentration-time profiles.
  
  
  RESULTS
  The mean AUC0-t, AUC0-infinity, and Cmax were 501.61 ng x h/ml, 518.88 ng x h/ ml and 98.02 ng/ml, respectively for the test formulation and 507.10 ng x h/ml, 525.20 ng x h/ml and 97.82 ng/ml, respectively, for the reference formulation. The median Tmax, for both formulations was 0.75 h. Plasma elimination half-lives (t1/2) were 3.44 h (test) and 3.38 h (reference). The point estimates and 90% confidence intervals (CI) for AUC0-t, AUC0-infinity and Cmax were 98.92% (94.62-103.41%), 98.80% (94.51-103.28%) and 100.20% (91.43-109.81%), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration guidelines.
  
  
  CONCLUSIONS
  These results indicate that the two formulations of dexamethasone 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; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D003907:Dexamethasone / Q000008:administration & dosage / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D007214:Indonesia; D008297:Male; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D013607:Tablets; D003907:Dexamethasone