Study |
Dose (mg) |
Parameter (units) |
Analyte |
Adjusted Geometric Mean (SD)
Min; Max |
Ratio (Test/Reference) of
Adjusted
Geometric Mean (%) |
90% Confidence Intervals (%) |
Test |
Reference |
Lower |
Upper |
ST vs. MT |
10 |
AUCinf (ng.h/mL) |
ATV |
16.73 (8.26)
5.90; 42.20 |
17.55 (8.80)
5.68; 51.40 |
95.34 |
91.33 |
99.52 |
AUClast (ng.h/mL) |
ATV |
14.02 (7.89)
4.42; 39.50 |
17.55 (8.72)
4.73; 48.20 |
95.79 |
91.07 |
100.76 |
Cmax (ng/mL) |
ATV |
2.34 (1.45)
0.78; 8.23 |
2.56 (1.23)
0.96; 5.97 |
91.41 |
83.39 |
100.20 |
ST vs. MT |
80 |
AUCinf (ng.h/mL) |
ATV |
151.03 (100.78)
66.00; 794.00 |
152.88 (120.19)
57.90; 864.00 |
98.79 |
94.57 |
103.20 |
AUClast (ng.h/mL) |
ATV |
144.94 (100.57)
58.40; 786.00 |
146.81 (119.71)
51.80; 856.00 |
98.72 |
94.41 |
103.23 |
Cmax (ng/mL) |
ATV |
36.38 (31.71)
9.34; 193.00 |
34.76 (36.47)
7.25; 224.00 |
104.66 |
95.73 |
114.42 |
CT vs. MT |
10 |
AUCinf (ng.h/mL) |
ATV |
22.78 (9.73)
9.05; 61.70 |
22.13 (9.68)
9.83; 65.80 |
102.91 |
99.02 |
106.96 |
O-ATV |
24.46 (9.52)
10.10; 72.40 |
24.30 (9.67)
10.40; 70.50 |
100.64 |
97.51 |
103.88 |
AUClast (ng.h/mL) |
ATV |
20.48 (9.57)
7.31; 60.10 |
19.80 (9.26)
7.00; 64.30 |
103.48 |
99.34 |
107.79 |
O-ATV |
16.73 (9.59)
7.52; 70.60 |
16.73 (9.71)
8.52; 68.40 |
101 |
97.68 |
104.44 |
Cmax (ng/mL) |
ATV |
3.80 (2.22)
1.45; 14.30 |
3.51 (1.58)
1.13; 8.70 |
108.13 |
98.75 |
118.40 |
O-ATV |
1.49 (0.86)
0.48; 5.32 |
1.52 (0.91)
0.57; 5.54 |
97.98 |
92.34 |
103.96 |
CT vs. MT |
80 |
AUCinf (ng.h/mL) |
ATV |
131.13 (58.71)
64.20; 364.00 |
124.03 (53.83)
60.00; 317.00 |
105.73 |
100.69 |
111.02 |
O-ATV |
163.8 (75.99)
54.90; 514.00 |
156.5 (69.81)
64.70; 472.00 |
104.65 |
100.40 |
109.08 |
AUClst (ng.h/mL) |
ATV |
127.49 (59.13)
60.60; 363.00 |
120.79 (53.36)
57.60; 313.00 |
105.55 |
100.34 |
111.03 |
O-ATV |
159.16 (74.69)
51.20; 492.00 |
151.88 (69.19)
61.40; 461.00 |
104.79 |
100.41 |
109.37 |
Cmax (ng/mL) |
ATV |
29.24 (15.88)
7.02; 91.50 |
28.85 (16.15)
9.27; 99.20 |
101.37 |
92.39 |
111.23 |
O-ATV |
22.52 (15.82)
7.29; 95.30 |
22.28 (12.22)
6.60; 63.20 |
101.11 |
93.08 |
109.84 |
