ABSOLUTE BIOAVAILABILITY OF BROMFENAC IN HUMANS

OBJECTIVE: To estimate absolute bioavailability of bromfenac and to co mpare its pharmacokinetics after intravenous and oral administration. DESIGN: This was a randomized, open-label, single-dose, crossover stud y conducted under fasting conditions with a washout period of at least 48 hours between doses. Each subject received a 50-mg dose of bromfen ac both intravenously and orally followed by collection of blood sampl es at specified time intervals, Bromfenac plasma concentrations were m easured by using a validated HPLC method with ultraviolet detection. S ETTING: The study was conducted at the Drug Evaluation Unit, Hennepin County Medical Center, Minneapolis, MN, SUBJECTS: The participants con sisted of 12 healthy subjects between 18 and 45 years of age and withi n +/-15% of ideal body weight. RESULTS: The mean +/- SD absolute bioav ailability of bromfenac was 67% +/- 20%, CONCLUSIONS: The pharmacokine tic parameters of bromfenac were similar after intravenous and oral ad ministration, suggesting that the prototype oral dosage form is optima l and that the observed intersubject variability is due to bromfenac i tself, not the type of dosage form.