| Reference - Fasting |
| Parameter |
Unit |
N |
Mean |
DP |
Min |
Median |
Max |
CV% |
| AUC % extrap |
(%) |
8 |
0.36 |
0.14 |
0.21 |
0.30 |
0.55 |
38.37 |
| AUCall |
([ng*hr]/mL) |
8 |
262.66 |
75.38 |
158.57 |
274.48 |
364.17 |
28.70 |
| AUCinf |
([ng*hr]/mL) |
8 |
263.21 |
75.43 |
159.11 |
275.36 |
364.60 |
28.66 |
| AUClast |
([ng*hr]/mL) |
8 |
262.31 |
75.34 |
158.24 |
273.99 |
363.85 |
28.72 |
| Clast |
(ng*/mL) |
8 |
1.47 |
0.33 |
1.21 |
1.29 |
2.08 |
22.51 |
| Cmax |
(ng*/mL) |
8 |
529.38 |
265.22 |
107.00 |
504.00 |
936.00 |
50.10 |
| Ke |
(1/hr) |
8 |
1.73 |
0.34 |
1.25 |
1.66 |
2.41 |
19.85 |
| T1/2 |
(hr) |
8 |
0.41 |
0.08 |
0.29 |
0.42 |
0.56 |
18.96 |
| Tlast |
(hr) |
8 |
3.40 |
0.60 |
2.70 |
3.25 |
4.50 |
17.79 |
| Tmax |
(hr) |
8 |
0.66 |
0.27 |
0.50 |
0.50 |
1.25 |
40.41 |
Test – Fasting |
| Parameter |
Unit |
N |
Mean |
DP |
Min |
Median |
Max |
CV% |
| AUC % extrap |
(%) |
8 |
0.30 |
0.14 |
0.17 |
0.27 |
0.62 |
46.95 |
| AUCall |
([ng*hr]/mL) |
8 |
281.79 |
82.46 |
202.16 |
260.19 |
449.09 |
29.26 |
| AUCinf |
([ng*hr]/mL) |
8 |
282.30 |
82.47 |
202.50 |
261.06 |
449.59 |
29.21 |
| AUClast |
([ng*hr]/mL) |
8 |
281.51 |
82.44 |
201.99 |
259.87 |
448.80 |
29.28 |
| Clast |
(ng*/mL) |
8 |
1.25 |
0.14 |
1.04 |
1.29 |
1.39 |
11.21 |
| Cmax |
(ng*/mL) |
8 |
458.63 |
134.09 |
169.00 |
462.00 |
638.00 |
29.24 |
| Ke |
(1/hr) |
8 |
1.72 |
0.45 |
0.82 |
1.78 |
2.15 |
26.12 |
| T1/2 |
(hr) |
8 |
0.44 |
0.17 |
0.32 |
0.39 |
0.85 |
39.48 |
| Tlast |
(hr) |
8 |
3.67 |
0.77 |
2.67 |
3.75 |
5.00 |
21.00 |
| Tmax |
(hr) |
8 |
0.56 |
0.18 |
0.50 |
0.50 |
1.00 |
31.43 |
Reference - Fed |
| Parameter |
Unit |
N |
Mean |
DP |
Min |
Median |
Max |
CV% |
| AUC % extrap |
(%) |
8 |
0.24 |
0.10 |
0.11 |
0.22 |
0.36 |
40.05 |
| AUCall |
([ng*hr]/mL) |
8 |
300.74 |
91.40 |
183.74 |
287.15 |
433.11 |
30.39 |
| AUCinf |
([ng*hr]/mL) |
8 |
301.16 |
91.51 |
183.69 |
287.56 |
433.46 |
30.38 |
| AUClast |
([ng*hr]/mL) |
8 |
300.49 |
91.51 |
183.02 |
286.97 |
432.98 |
30.45 |
| Clast |
(ng*/mL) |
8 |
1.21 |
0.14 |
1.03 |
1.15 |
1.44 |
11.53 |
| Cmax |
(ng*/mL) |
8 |
462.88 |
425.85 |
117.00 |
331.50 |
1420.00 |
92.00 |
| Ke |
(1/hr) |
8 |
1.94 |
0.36 |
1.08 |
2.03 |
2.17 |
18.50 |
| T1/2 |
(hr) |
8 |
0.38 |
0.11 |
0.32 |
0.34 |
0.64 |
29.17 |
| Tlast |
(hr) |
8 |
4.14 |
0.61 |
3.25 |
4.00 |
5.00 |
14.63 |
| Tmax |
(hr) |
8 |
1.00 |
0.37 |
0.33 |
1.09 |
1.33 |
36.74 |
Test - Fed |
| Parameter |
Unit |
N |
Mean |
DP |
Min |
Median |
Max |
CV% |
| AUC % extrap |
(%) |
8 |
0.27 |
0.20 |
0.12 |
0.22 |
0.75 |
75.57 |
| AUCall |
([ng*hr]/mL) |
8 |
344.67 |
114.50 |
204.15 |
332.19 |
549.40 |
33.22 |
| AUCinf |
([ng*hr]/mL) |
8 |
345.22 |
114.57 |
204.77 |
332.77 |
549.93 |
33.19 |
| AUClast |
([ng*hr]/mL) |
8 |
344.42 |
114.63 |
203.23 |
332.05 |
549.25 |
33.28 |
| Clast |
(ng*/mL) |
8 |
1.25 |
0.26 |
1.01 |
1.15 |
1.84 |
21.08 |
| Cmax |
(ng*/mL) |
8 |
704.89 |
556.95 |
94.10 |
605.00 |
1760.00 |
79.01 |
| Ke |
(1/hr) |
8 |
1.69 |
0.44 |
1.18 |
1.68 |
2.47 |
25.97 |
| T1/2 |
(hr) |
8 |
0.43 |
0.11 |
0.28 |
0.41 |
0.59 |
25.23 |
| Tlast |
(hr) |
8 |
3.67 |
0.66 |
3.00 |
3.50 |
5.00 |
18.13 |
| Tmax |
(hr) |
8 |
0.83 |
0.85 |
0.33 |
0.50 |
2.83 |
102.62 |
|
