title: Bioequivalence study of two brands of meloxicam tablets in healthy human Pakistani male subjects.
abstract: Meloxicam is a cyclooxygenase-2, preferential inhibitor non-steroidal anti-inflammatory drug (NSAID) and belongs to an enolic acid (oxicam) class used for the treatment of osteoarthritis and rheumatoid arthritis. The purpose of this single dose randomized cross-over study was to assess bioequivalence of two brands of oral meloxicam tablets (Xobix manufactured by Hilton Pharma (Pvt.) Ltd. as a reference and tablet Melfax by AGP (Pvt.) Ltd. as a test) in 18 healthy male volunteers in local population of Pakistan. The data obtained were subjected to non-compartment model pharmacokinetic analysis. The value of C(max) calculated in present study was 1.051 +/- 3.762 microg/mL for reference formulation and 1.023 +/- 4.102 microg/mL (the mean +/- SEM) for test sample. The value of T(max) was 3.125 +/- 1.004 h for reference standard and 3.750 +/- 1.469 h (the mean +/- SEM) for test sample. The area under the curve from zero to infinity (AUC(0-72)) was 28.667 +/- 0.414 microg x h/mL for reference standard and 28.367 +/- 0.333 microg x h/mL for test sample (the mean +/- SEM). The t1/2 values were 13.694 +/- 0.568 h and 13.319 +/- 0.567 h (the mean +/- SEM) for reference formulation and for test sample, respectively. The test formulation was found to be bioequivalent to reference formulation based on the pharmacokinetic parameters.
authors.affiliation: Faculty of Pharmacy and Alternative Medicines, Islamia University of Bahawalpur, Bahawalpur-63100, Pakistan.
authors.forename: Mahmood
authors.initials: M
authors.lastname: Ahmad
authors.forename: Ghulam
authors.initials: G
authors.lastname: Murtaza
authors.forename: Naveed
authors.initials: N
authors.lastname: Akhtar
authors.forename: Faryal
authors.initials: F
authors.lastname: Siddique
authors.forename: Shujaat Ali
authors.initials: SA
authors.lastname: Khan
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D018592:Cross-Over Studies; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D006207:Half-Life; D006801:Humans; D008297:Male; D000077239:Meloxicam; D008954:Models, Biological; D010154:Pakistan; D012015:Reference Standards; D013607:Tablets; D013810:Therapeutic Equivalency; D013843:Thiazines / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D013844:Thiazoles / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D055815:Young Adult
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D013607:Tablets; D013843:Thiazines; D013844:Thiazoles; D000077239:Meloxicam