Study design
SAD
This was a double-blind, randomized, placebo-controlled, and sequential ascending single- and multiple-dose study of oral ceftibuten.Three doses were studied. The 400 and 600 mg dosing groups consisted of 10 subjects (8 active drug and 2 placebo), while the 800 mg group consisted of 20 subjects (16 active drug and 4 placebo). Within each group, subjects received a single oral dose on Days 1 and 4 (SAD); then, after the first dose on Day 4, 12-hourly doses were administered for 7 days (Days 4–10) (MAD).