Effects of Age and Gender on the Pharmacokinetics of Bromfenac in Healthy Volunteers

ObjectiveTo compare the pharmacokinetic parameters of bromfenac, a nonsteroidal antiinflammatory drug under development, in healthy volunteers of various ages and either gender, after single and multiple doses.DesignOpen-label, single- and multiple-dose, nonrandomized, parallel study.ParticipantsTwenty young (18–45 y), 12 young-elderly (65–74 y), and 12 elderly (75–85 y) subjects were studied. Half of the subjects in each group were women.InterventionsBromfenac was given as a single 50-mg dose and then as 50-mg doses every 12 hours for 3 additional days. Twelve blood samples were collected for 12 hours after the first and last doses.Main Outcome MeasuresBromfenac concentrations were measured by using an HPLC procedure with ultraviolet detection. Unbound bromfenac concentrations were measured by equilibrium dialysis. Pharmacokinetic analysis was performed by noncompartmental techniques.ResultsNo significant differences related to gender were detected. Significant differences were observed in half-life (t1/...