title: Bioequivalence study of two meloxicam tablet formulations after single-dose administration in healthy Thai male volunteers.
abstract: OBJECTIVE
  To compare the bioavailability of two meloxicam tablet formulations (MEL-OD, Zydus Cadila Healthcare Limited, India, as a test formulation and Mobic, Boehringer Ingelheim International GmbH, Germany, as a reference formulation) in healthy Thai male volunteers under fasting condition.
  
  
  METHODS
  A randomized, 2-treatment, 2-period, 2-sequence, single dose, crossover with a washout period of 2 weeks, was conducted in 26 healthy Thai male volunteers. Blood samples were collected 0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 24, 36, 48, 72 and 96 h post dose. Plasma concentrations of meloxicam were determined using a validated HPLC method. The pharmacokinetic parameters of meloxicam were determined using a non-compartmental model.
  
  
  RESULTS
  The mean Cmax was 1,027.32 +/- 251.91 and 1,151.89 +/- 282.58 ng/ml while the mean AUC0-t was 34,024.31 +/- 11,811.68 and 35,137.66 +/- 11,970.47 ng x h/ml for the test and reference formulation, respectively. In addition, the mean AUC0-infinity for test formulation was 37,241.44 +/- 14,888.85 ng x h/ml and for the reference formulation was 39,541.04 +/- 16,624.64 ng x h/ml. The median tmax for the test and reference formulation was 4.50 (range 2.00 - 12.00) and 4.50 (range 3.00 - 10.00), respectively. The geometric means (90% confidence intervals) of the ratio for the log-transformed pharmacokinetic parameters, Cmax, AUC0-t and AUC0-inf were 0.8919 (82.58 - 96.32%), 0.9697 (89.46 - 105.10%) and 0.9525 (87.68 - 103.47%), respectively.
  
  
  CONCLUSIONS
  It can be concluded that two meloxicam tablet formulations are bioequivalent both in term of rate and extent of absorption after single-dose administration under fasting condition.
authors.affiliation: Department of Pharmacology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: P
authors.initials: P
authors.lastname: Tangsucharit
authors.forename: J
authors.initials: J
authors.lastname: Kampan
authors.forename: S
authors.initials: S
authors.lastname: Kanjanawart
authors.forename: D
authors.initials: D
authors.lastname: Gaysonsiri
authors.forename: S
authors.initials: S
authors.lastname: Vannaprasaht
authors.forename: S
authors.initials: S
authors.lastname: Tiamkao
authors.forename: K
authors.initials: K
authors.lastname: Phunikhom
authors.forename: S
authors.initials: S
authors.lastname: Simasathiansophon
authors.forename: P
authors.initials: P
authors.lastname: Puapairoj
authors.forename: W
authors.initials: W
authors.lastname: Tassaneeyakul
mesh_terms: D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D000077239:Meloxicam; D013607:Tablets; D013785:Thailand; D013810:Therapeutic Equivalency; D013843:Thiazines / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013844:Thiazoles / Q000008:administration & dosage / Q000493:pharmacokinetics*; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D013607:Tablets; D013843:Thiazines; D013844:Thiazoles; D000077239:Meloxicam