Absolute bioavailability of bromfenac in humans.

OBJECTIVE

To estimate absolute bioavailability of bromfenac and to compare its pharmacokinetics after intravenous and oral administration.

DESIGN

This was a randomized, open-label, single-dose, crossover study conducted under fasting conditions with a washout period of at least 48 hours between doses. Each subject received a 50-mg dose of bromfenac both intravenously and orally followed by collection of blood samples at specified time intervals. Bromfenac plasma concentrations were measured by using a validated HPLC method with ultraviolet detection.

SETTING

The study was conducted at the Drug Evaluation Unit. Hennepin County Medical Center, Minneapolis, MN.

SUBJECTS

The participants consisted of 12 healthy subjects between 18 and 45 years of age and within +/-15% of ideal body weight.

RESULTS

The mean +/- SD absolute bioavailability of bromfenac was 67% +/- 20%.

CONCLUSIONS

The pharmacokinetic parameters of bromfenac were similar after intravenous and oral administration, suggesting that the prototype oral dosage form is optimal and that the observed intersubject variability is due to bromfenac itself, not the type of dosage form.