Bioequivalence evaluation of two brands of amoxicillin/clavulanic acid 250/125 mg combination tablets in healthy human volunteers: use of replicate design approach.
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.
Idkaidek
Nasir M
NM
College of Pharmacy, University of Science and Technology, Irbid, Jordan. dekaidek@just.edu.jo
Al-Ghazawi
Ahmad
A
Najib
Naji M
NM
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
D004338:Drug Combinations; D013607:Tablets; D019980:Amoxicillin-Potassium Clavulanate Combination