A food interaction study of bromfenac, naproxen sodium, and placebo in cesarean section patients.
Objective: This double-blind study was to compare the effect of food on the analgesic response to bromfenac, naproxen sodium, and placebo.Methods: Single doses of bromfenac (BRO) 25 mg, naproxen Na (NAP) 550 mg, or placebo (PLA) were given to 284 patients with moderate or severe pain following cesarean section. A standard breakfast was provided for the "fed" patients. "Fasted" patients received no food 3 h before and 1 h after the dose. Treatments were compared over 8 h using standard scales for pain intensity and pain relief. Plasma levels of BRO were measured in 7 fasted and 12 fed patients.Results: BRO and NAP were significantly superior to PLA; food did not affect the response to any treatment: As expected, mean peak plasma levels of bromfenac were reduced by food by about 65%.Conclusion: Food reduces the bioavailability of bromfenac but has no effect on the analgesic response.
Sunshine
A
Analgesic Development Ltd, New York, New York, USA
Olson
NZ
Zighelboim
I
Wajdula
JS