TABLE 5.
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 |
BE0t indicates studies that were equivalent for both AUC0t and Cmax. BEinf indicates studies that were equivalent for both AUCinf and Cmax.
For the studies, 120 mg of Doryx MPC and 100-mg Doryx tablets were used. For each group, 1,000 simulated studies were performed.