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. 2017 Feb 23;61(3):e02401-16. doi: 10.1128/AAC.02401-16

TABLE 4.

Model-predicted bioequivalence results calculated using the ANOVA methoda

Study size and dosingb % AUC0t % AUCinf % Cmax % Tmax % BE0t % BEinf
12 participants per study
    Doryx MPC vs Doryx tablet (Fasted) 89.8 87.9 88.1 15.7 79.2 77.8
    Doryx MPC vs Doryx tablet (Fed) 90.5 86.7 7.5 0 6 5.6
    Doryx MPC vs Doryx MPC (Fed/Fasted) 62.4 60.5 0 0 0 0
    Doryx tablet vs Doryx tablet (Fed/Fasted) 65.2 61.1 12.2 5 8.6 8.1
24 participants per study (1,000 simulated studies)
    Doryx MPC vs Doryx tablet (Fasted) 99.7 99.6 99.8 58.6 99.5 99.4
    Doryx MPC vs Doryx tablet (Fed) 99.6 99.5 7.6 0 7.4 7.3
    Doryx MPC vs Doryx MPC (Fed/Fasted) 88 85.9 0 0 0 0
    Doryx tablet vs Doryx tablet (Fed/Fasted) 88.4 86 18.4 6.3 16.8 16.3
28 participants per study
    Doryx MPC vs Doryx tablet (Fasted) 99.8 99.7 99.8 67.4 99.6 99.5
    Doryx MPC vs Doryx tablet (Fed) 99.8 99.6 8.9 0 8.8 8.7
    Doryx MPC vs Doryx MPC (Fed/Fasted) 92 90.6 0 0 0 0
    Doryx tablet vs Doryx tablet (Fed/Fasted) 93.6 91.2 19 4.7 17.8 17.7
36 participants per study
    Doryx MPC vs Doryx tablet (Fasted) 100 100 100 82 100 100
    Doryx MPC vs Doryx tablet (Fed) 100 100 9.1 0 9.1 9.1
    Doryx MPC vs Doryx MPC (Fed/Fasted) 95.8 95.1 0 0 0 0
    Doryx tablet vs Doryx tablet (Fed/Fasted) 96.4 95.3 21.2 5.8 20.8 20.7
a

Percent AUCinf, AUC0t, Cmax, and Tmax indicates, respectively, the power percentage for a study to display equivalence of AUCinf, AUC0t, Cmax, and Tmax for the crossover designs indicated. Percent BE0t and BEinf indicates, respectively, the power percentage for a study to display bioequivalence via AUC0t and Cmax and via AUCinf and Cmax for the crossover designs indicated.

b

For the studies, 120 mg of Doryx MPC and 100-mg Doryx tablets were used. For each group, 1,000 simulated studies were performed.