Bioequivalence study of the two 1.5 g cefoperazone and sulbactam IM injections in Thai healthy male volunteers.
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.
Kaewvichit
Sayam
S
Department of Pharmaceutical Science, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand. sayamk@pharmacy.cmu.ac.th
Yotsawimonwat
Songwut
S
Taesotikul
Wandee
W
Niwatananun
Wirat
W
Duangrat
Chadarat
C
Wongsinsup
Chokchai
C
Thongsawat
Satawat
S
Salee
Parichat
P
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
D000900:Anti-Bacterial Agents; D002438:Cefoperazone; D013407:Sulbactam