TABLE 4

Summary of food effect on relative bioavailability of tebipenem in the SAD phase

Drug and doseAUClastCmax
% ratio of LSa
means (fasted/fed)
90% CI% ratio of LS
means (fasted/fed)
90% CI
TBPM-PI-HBr
    12 h, 300 mg (n = 6)185.9146.9, 235.1148.6107.3, 205.8
    12 h, 600 mg (n = 6)273.5194.8, 384.1166.2101.2, 272.7
    2 h, 300 mg (n = 6)74.958.4, 96.043.330.7, 61.2
    4 h, 300 mg (n = 6)81.163.0, 104.347.625.6, 88.5
    4 h, 600 mg (n = 6)107.773.6, 157.583.646.1, 151.5
    6 h, 300 mg (n = 6)151.9125.3, 184.3124.396.4, 160.3
    IR, 300 mg (n = 6)97.571.1, 133.852.931.7, 88.3
    IR, 600 mg (n = 6)108.173.9, 158.090.341.7, 195.6
Orapenem, 300 mg (n = 7)70.261.6, 80.050.132.2, 77.8
  • a LS, least square.