Comparative bioavailability of two oral formulations of ketorolac tromethamine: Dolac and Exodol.
The bioavailability of ketorolac after administration of two oral formulations containing 10 mg of ketorolac tromethamine, Exodol and Dolac, to 12 healthy Mexican volunteers was compared. Subjects received both formulations according to a randomized crossover design and blood samples were drawn at selected times during 24 h. Ketorolac plasma concentrations were determined by HPLC and individual plasma-concentration-against-time curves were constructed. Maximal plasma concentration and AUC0-24 values were compared by analysis of variance followed by Westlake's confidence interval test. 90% confidence limits ranged from 80 to 125% for Cmax and from 85 to 118% for AUC0-24. It is concluded that the two assayed formulations are bioequivalent.
Departamento de Farmacología y Toxicología, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional, México, D.F., Mexico.
F J
FJ
Flores-Murrieta
V
V
Granados-Soto
G
G
Castañeda-Hernández
J E
JE
Herrera
E
E
Hong
D000284:Administration, Oral; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D001682:Biological Availability; D004338:Drug Combinations; D006801:Humans; D020911:Ketorolac Tromethamine; D008297:Male; D013607:Tablets; D014046:Tolmetin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D014325:Tromethamine / Q000008:administration & dosage / Q000493:pharmacokinetics*
D000700:Analgesics; D004338:Drug Combinations; D013607:Tablets; D014325:Tromethamine; D020911:Ketorolac Tromethamine; D014046:Tolmetin