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

TABLE 5.

BE0t and BEinf studies that included 1 with the 90% CI of ln-transformed test-to-reference ratios for AUC0t, AUCinf, and Cmaxa

Study size and dosingb No. of BE0t studies from the 1,000 simulated replicates % of BE0t studies that included 1 within the 90% CI of the test-to-reference ratio for AUC0t and Cmax No. of BEinf studies from the 1,000 simulated replicates % of BEinf studies that included 1 within the 90% CI of the test-to-reference ratio for AUCinf and Cmax
12 participants per study
    Doryx MPC vs Doryx tablet (Fasted) 792 84.85 778 85.35
    Doryx MPC vs Doryx tablet (Fed) 60 56.67 56 51.79
    Doryx MPC vs Doryx MPC (Fed/Fasted) 0 0
    Doryx tablet vs Doryx tablet (Fed/Fasted) 86 44.19 81 43.21
24 participants per study
    Doryx MPC vs Doryx tablet (Fasted) 995 64.02 994 65.59
    Doryx MPC vs Doryx tablet (Fed) 74 4.05 73 4.11
    Doryx MPC vs Doryx MPC (Fed/Fasted) 0 0
    Doryx tablet vs Doryx tablet (Fed/Fasted) 168 4.17 163 4.91
28 participants per study
    Doryx MPC vs Doryx tablet (Fasted) 996 60.84 995 61.91
    Doryx MPC vs Doryx tablet (Fed) 88 3.41 87 4.60
    Doryx MPC vs Doryx MPC (Fed/Fasted) 0 0
    Doryx tablet vs Doryx tablet (Fed/Fasted) 178 1.12 177 1.13
36 participants per study
    Doryx MPC vs Doryx tablet (Fasted) 1000 55.10 1000 57.50
    Doryx MPC vs Doryx tablet (Fed) 91 1.10 91 1.10
    Doryx MPC vs Doryx MPC (Fed/Fasted) 0 0
    Doryx tablet vs Doryx tablet (Fed/Fasted) 208 0 207 0
a

BE0t indicates studies that were equivalent for both AUC0t and Cmax. BEinf indicates studies that were equivalent for both AUCinf and Cmax.

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.