COMPARATIVE BIOAVAILABILITY OF 2 ORAL FORMULATIONS OF KETOROLAC TROMETHAMINE - DOLAC(R) AND EXODOL(R)

The bioavailability of ketorolac after administration of two oral form ulations containing 10 mg of ketorolac tromethamine, Exodol(R) and Dol ac(R), to 12 healthy Mexican volunteers was compared. Subjects receive d both formulations according to a randomized crossover design and blo od samples were drawn at selected times during 24 h. Ketorolac plasma concentrations were determined by HPLC and individual plasma-concentra tion-against-time curves were constructed. Maximal plasma concentratio n and AUC(0-24) values were compared by analysis of variance followed by Westlake's confidence interval test. 90% confidence limits ranged f rom 80 to 125% for C-max and from 85 to 118% for AUC(0-24). It is conc luded that the two assayed formulations are bioequivalent.