title: Bioequivalence study of the two 1.5 g cefoperazone and sulbactam IM injections in Thai healthy male volunteers.
abstract: OBJECTIVE
  To perform a bioequivalence study of the two 1.5 g cefoperazone (1.0 g) and sulbactam (0.5 g) between Cefper and Sulperazon injections.
  
  
  METHODS
  The present study was performed in 24 Thai healthy male volunteers who were intramuscularly injected a single dose of 1.5 g cefoperazone and sulbactam. A single dose, two periods, two sequences, double blind randomized crossover with a one-week washout period was used. Blood samples were collected before and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours after intramuscular injection and determined for cefoperazone and sulbactam plasma concentration by validated HPLC-UV methods. The pharmacokinetic parameters were analyzed by noncompartmental analysis and the ANOVA was carried out.
  
  
  RESULTS
  Tax of both cefoperazone and sulbactam for volunteers who were injected with either Cefper or Sulperazon injection were not significantly different (p > 0.05). The 90% confidence intervals of the log of ratio of either C(max) or AUC(last) or AUC(inf) of both cefoperazone and sulbactam between 1.5 g Cefper and Sulperazon injections were within the bioequivalence range of 0.80-1.25.
  
  
  CONCLUSIONS
  The 1.5 g cefoperazone and sulbactam injection of Cefper and Sulperazone used in the present study are bioequivalent.
authors.affiliation: Department of Pharmaceutical Science, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand. sayamk@pharmacy.cmu.ac.th
authors.forename: Sayam
authors.initials: S
authors.lastname: Kaewvichit
authors.forename: Songwut
authors.initials: S
authors.lastname: Yotsawimonwat
authors.forename: Wandee
authors.initials: W
authors.lastname: Taesotikul
authors.forename: Wirat
authors.initials: W
authors.lastname: Niwatananun
authors.forename: Chadarat
authors.initials: C
authors.lastname: Duangrat
authors.forename: Chokchai
authors.initials: C
authors.lastname: Wongsinsup
authors.forename: Satawat
authors.initials: S
authors.lastname: Thongsawat
authors.forename: Parichat
authors.initials: P
authors.lastname: Salee
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000494:pharmacology; D019540:Area Under Curve; D002438:Cefoperazone / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000494:pharmacology; D002851:Chromatography, High Pressure Liquid; D016001:Confidence Intervals; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D013407:Sulbactam / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000494:pharmacology; D013785:Thailand; D013810:Therapeutic Equivalency
chemical_list: D000900:Anti-Bacterial Agents; D002438:Cefoperazone; D013407:Sulbactam