COMPARISON OF STANDARD AND TEST FORMULATIONS OF KETOROLAC - A PHARMACOKINETIC AND BIOEQUIVALENCE STUDY IN INDIAN VOLUNTEERS

In a crossover study, eight Indian volunteers received two 10-mg table ts of a standard or test formulation of oral ketorolac. Blood samples were collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after drug administration. The maximum concentration (C(max)) +/- SEM of the standard formulation at 0.5 hour was 2163.42 +/- 61.89 ng/ml; t he C(max) of the test formulation at the same time was 2168.80 +/- 86. 31 ng/ml. The area under the curve (AUC) +/- SEM was 7716.73 +/- 310.3 3 and 7786.24 +/- 332.90 ng/ml/hr for the standard and test formulatio ns, respectively. Comparison of the AUCs demonstrated that the bioavai lability of the test formulation was 100.9% of that of the standard fo rmulation. The results of this study showed that the standard and test formulations of ketorolac were bioequivalent.