Bioequivalence Study of the Two 1.5 g Cefoperazone and Sulbactam IM Injections in Thai Healthy Male Volunteers
Sayam Kaewvichit PhD*, Songwut Yotsawimonwat PhD*, Wandee Taesotikul MSc*, Wirat Niwatananun PhD*, Chadarat Duangrat PhD*, Chokchai Wongsinsup MSc*, Satawat Thongsawat MD**, Parichat Salee MD**
Affiliation : * Faculty of Pharmacy, Chiang Mai University, Chiang Mai ** Faculty of Medicine, Chiang Mai University, Chiang Mai
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.
Material and Method: The present study was performed in 24 Thai healthy male volunteers who were intra-
muscularly 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 : Tmax 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 Cmax or AUClast or AUCinf of both cefoperazone and sulbactam between 1.5 g Cefper® and
Sulperazon® injections were within the bioequivalence range of 0.80-1.25.
Conclusion : The 1.5 g cefoperazone and sulbactam injection of Cefper® and Sulperazon® used in the present
study are bioequivalent.
Keywords : Bioequivalence, Cefoperazone, Sulbactam, Cefper®, Sulperazon®
