Bioequivalence assessment of two formulations of celecoxib: Open label, single dose and two-way cross over study in healthy human male volunteers

Abstract

The purpose of this study was to assess bioequivalence of two marketed formulations of celecoxib capsules in healthy human male volunteers. The study was conducted according to a single dose, randomized sequence, open label, two-period and crossover design. Both test and reference formulations comprised labeled dose of 200 mg celecoxib and were administered to each subject after an overnight fasting on two treatment days separated by one week of washout period. After drug administration, blood samples were collected at predetermined time points for a period of 48 h. Plasma separated from blood was analyzed for celecoxib concentrations using validated reverse phase-high performance liquid chromatographic (RP-HPLC) method. Various pharmacokinetic parameters including C max , T max , AUC 0-t , AUC 0-∞ , T 1/2 and K el were determined from the plasma concentration for both formulations. C max , AUC 0-t and AUC 0-∞ , were evaluated for bioequivalence after log-transformation of data. The 90% confidence intervals for the ratio of C max (93.26 to 100.70%), AUC 0-t (87.00 to 117.50%) and AUC 0-∞ (86.49 to 118.56%), values for the test and reference products were within the acceptance range of 80 to 125%, proposed by Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA). Based on these statistical inferences, it was concluded that two formulations of celecoxib are bioequivalent in their rate and extent of absorption.

Bioequivalence Evaluation of Two Formulations of Celecoxib 200mg Capsules in Healthy volunteers by using a validated LC/MS/MS method

“…We found that the mean C max of celecoxib was 705.3 ± 290.6ng/mL and 703.9 ± 329.9ng/mL in the test and reference products, and these findings were consistent with previous reports that assessed the results obtained following oral administration of 200mg celecoxib [12,16,17]. Meanwhile, the T max values of the two formulations were comparable to those obtained in earlier studies [18]. Above observations demonstrated that those formulations of celecoxib had similar absorption rates after oral administration.…”

Overcoming the Charged Ion Competition in Triple Quad Chemical Ionization Ion Source for Estimation of Celecoxib in Biological Matrix and its Application to Bioequivalence Study

“…Various analytical methods have been reported for the estimation of celecoxib using either HPLC (High Performance Liquid Chromatography) or LC-MS/MS (Liquid chromatography Mass spectrometry) procedures. Emami et al [7] and Akhtar et al [8] have developed the HPLC method with a very long run time (~10 min). Surya Prakasarao Kovvasu et al [9], Chang WK et al [10] have reported the LC-MS/MS method (Linearity range ~5-2 500 ng/mL) specific to a single formulation (200 mg dose) employing either costly solid phase extraction method or crude (protein precipitation) method.…”