title: Two-way crossover bioequivalence study of alendronate sodium tablets in healthy, non-smoking male volunteers under fasted conditions.
abstract: This study was conducted in order to assess the bioequivalence of two different formulations containing 70 mg alendronate sodium (CAS 121268-17-5) under fasted conditions. One hundred twenty-two healthy male volunteers were enrolled in an open label, randomized, crossover design with a wash-out period of 20 days in one study center. Urine samples were collected up to 36 h post-dose, and the concentrations of alendronic acid were determined using a high performance liquid chromatographic method with pre-derivatization and fluorescence detection (HPLC/FL) method. The mean Ae(0-t) were 604.24 +/- 348.73 microg and 627.36 +/- 327.99 microg, while the mean R(max) were 193.87 +/- 114.68 microg/h and 202.00 +/- 107.83 microg/h for the test and reference formulations, respectively. The T(max) of the test and reference tablets were 1.26 +/- 0.58 h and 1.26 +/- 0.51 h, respectively. No significant differences of pharmacokinetic parameters between the two studied formulations were found. The 90% confidence intervals for the primary target parameters, intra-individual ratios for Ae(0-t) and R(max) of alendronic acid, were between 0.86-1.00 and 0.85-1.01, respectively, and thus within the acceptance range for bioequivalence criteria. In the light of the present study it can be concluded that the test formulation is bioequivalent to the reference formulation.
authors.affiliation: Ranbaxy Pharmaceuticals Canada Inc., Toronto, Ontario, Canada.
authors.forename: Nageshwar Rao
authors.initials: NR
authors.lastname: Thudi
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Gagnon
authors.forename: Saleh
authors.initials: S
authors.lastname: Hussain
authors.forename: Zohreh
authors.initials: Z
authors.lastname: Abolfathi
authors.forename: Ajay
authors.initials: A
authors.lastname: Singla
authors.forename: Raveendra
authors.initials: R
authors.lastname: Pai
authors.forename: Sudershan
authors.initials: S
authors.lastname: Kumar
authors.forename: Tausif
authors.initials: T
authors.lastname: Monif
mesh_terms: D000328:Adult; D019386:Alendronate / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001682:Biological Availability; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D010349:Patient Compliance; D013607:Tablets; D055815:Young Adult
chemical_list: D050071:Bone Density Conservation Agents; D013607:Tablets; D019386:Alendronate