ISSN 2326-7267
International Journal of Pharmacy and Pharmacology ISSN 2326-7267 Vol. 14 (5), pp. 001-005, May, 2025. Available online at www.internationalscholarsjournals.org © International Scholars Journals
Full Length Research Paper
Comparative Bioavailability of Celecoxib Formulations in Healthy Males: A Randomized Crossover Study
Muhammad Akhtar1*, Mahmood Ahmad1, Irshad Ahmad1, Naveed Akhtar1, Asad Ullah Madni1, Muhammad Usman1, Muhammad Naeem Aamir1, Sonia Khiljee1, Mohammad Sualeh2, Shujaat Ali Khan3 and Muhammad Aleem4
1Faculty of Pharmacy and Alternative Medicine, the Islamia University of Bahawalpur, Pakistan.
2Faculty of Pharmacy, Federal Urdu University, Karachi, Pakistan.
3Department of Pharmaceutical Sciences, COMSATS Institute of Information Technology, Abbottabad, Pakistan.
4Department of Statistics, the Islamia University of Bahawalpur, Pakistan.
Accepted 7 October, 2024
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 Cmax, Tmax, AUC0-t, AUC0-∞, T1/2 and Kel were determined from the plasma concentration for both formulations. Cmax, AUC0-t and AUC0-∞, were evaluated for bioequivalence after log-transformation of data. The 90% confidence intervals for the ratio of Cm ax (93.26 to 100.70%), AUC0-t (87.00 to 117.50%) and AUC0-∞ (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.
Key words: Celecoxib, pharmacokinetics, bioequivalence, healthy human male volunteers.