title: Bioequivalence evaluation of two brands of amoxicillin/clavulanic acid 250/125 mg combination tablets in healthy human volunteers: use of replicate design approach.
abstract: The purpose of this study was to apply a replicate design approach to a bioequivalence study of amoxicillin/clavulanic acid combination following a 250/125 mg oral dose to 23 subjects, and to compare the analysis of individual bioequivalence with average bioequivalence. This was conducted as a 2-treatment 2-sequence 4-period crossover study. Average bioequivalence was shown, while the results from the individual bioequivalence approach had no success in showing bioequivalence. In conclusion, the individual bioequivalence approach is a strong statistical tool to test for intra-subject variances and also subject-by-formulation interaction variance compared with the average bioequivalence approach.
authors.affiliation: College of Pharmacy, University of Science and Technology, Irbid, Jordan. dekaidek@just.edu.jo
authors.forename: Nasir M
authors.initials: NM
authors.lastname: Idkaidek
authors.forename: Ahmad
authors.initials: A
authors.lastname: Al-Ghazawi
authors.forename: Naji M
authors.initials: NM
authors.lastname: Najib
mesh_terms: D000284:Administration, Oral; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004338:Drug Combinations; D004359:Drug Therapy, Combination / Q000097:blood / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency; D013997:Time Factors
chemical_list: D004338:Drug Combinations; D013607:Tablets; D019980:Amoxicillin-Potassium Clavulanate Combination