Rt. Sane et al., COMPARISON OF STANDARD AND TEST FORMULATIONS OF KETOROLAC - A PHARMACOKINETIC AND BIOEQUIVALENCE STUDY IN INDIAN VOLUNTEERS, Current therapeutic research, 54(4), 1993, pp. 425-429
Citations number
NO
Categorie Soggetti
Pharmacology & Pharmacy","Medicine, Research & Experimental
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.