Subjects
hypersensitivity, tobacco/nicotine abuse, allergic reaction
HYPERSENSITIVITY, ALLERGIC REACTION
Healthy adult subjects aged 18–55 years, with BMI 18.5–29.9 kg/mExclusion criteria included history of drug, alcohol, and/or tobacco/nicotine abuse; use of any prescription medication (with exception of hormone replacement therapy for females) within 14 days prior to Day 1; use of any over-the-counter medication, including herbal products and vitamins, within the 7 days prior to Day 1; use of antacids, H2 receptor blockers or proton pump inhibitors 3 days prior to Day 1; history of hypersensitivity or allergic reaction to ceftibuten, any of the excipients used in the formulation, or any beta-lactam antibiotics; females pregnant or lactating; calculated creatinine clearance <80 mL/min (Cockcroft–Gault method) at screening or Day 1; clinically significant abnormalities on laboratory values at screening or Day 1.