%0 Journal Article
%T Bioequivalence Evaluation of Two Formulations of Celecoxib 200 mg Capsules in Healthy volunteers by using a validated LC/MS/MS method
%A Chun-Hsu Juan
%A Guei-Tsern Guo
%A Hsuan-Kai Tzeng
%A Jhu-Ting Syu
%A Shen-Wei Chen
%A Wen-Kuei Chang
%A Yi-Hui Yeh
%A Yun-Chun Chen
%A Sy-Yeuan Ju
%J BioAnalytical Methods & BioEquivalence Studies (IJBMBS)
%D 2018
%R http://dx.doi.org/10.19070/2470-4490-150004
%X Abstract The bioequivalence study to compare a new formulation of celecoxib to its reference formulation was designed as an open-label, randomized, single-dose, two-way crossover, comparative bioavailability study by using a validated LC/MS/MS method. In order to determine the plasma concentrations of celecoxib, a sensitive LC/MS/MS method was developed. The method was validated to possess adequate specificity, linearity, precision, accuracy and stability. The linearity of calibration curve was assessed between the concentration intervals (5¨C2000 ng/mL) with a correlation coefficient over 0.999. Regarding pharmacokinetic investigation, the mean celecoxib AUC0-t values from the test and reference drug formulations were 7360.44 ¡À 1714.14 h£¿ng/mL and 7267.48 ¡À 2077.68 h£¿ng/mL, respectively, and the corresponding AUC0-¡Þ values were 8197.45 ¡À 2040.31 h£¿ng/mL and 7905.54 ¡À 2286.12 h£¿ng/mL, respectively. The Cmax of the test and reference drugs was 705.30 ¡À 290.63 ng/mL and 703.86 ¡À 329.91 ng/mL, respectively, and the corresponding Tmax was 3.4 ¡À 1.6 h and 2.9 ¡À 1.4 h. Lastly, the T1/2 values of the test and reference drugs were 13.9 ¡À 7.9 h and 12.9 ¡À 7.7 h, respectively. The 90% confidence intervals for AUC0-t, AUC0-¡Þ, and Cmax were 97.00-108.85, 98.01-112.09, and 93.20-116.13, respectively, satisfying the bioequivalence criteria of 80-125% range. In conclusion, these results demonstrated that the bioequivalence of two formulations of celecoxib was established successfully by utilizing present developed LC/MS/MS method
%K n/a
%U https://scidoc.org/IJBMBS-2470-4490-02-201.php