| |
Study 1. Single-Dose Proportionality Study |
Study 2. Single-Ascending-Dose Study |
| Desvenlafaxine |
Desvenlafaxine |
Venlafaxine
ER |
Placebo |
Total |
| Characteristic |
100, 300, and 600 mg
(n=24) |
150 mg
(n=6) |
255 mg
(n=6) |
300 mg
(n=6) |
450 mg
(n=6) |
600 mg
(n=6) |
750 mg
(n=5) |
750 mg (fasted)
(n=6) |
900 mg
(n=6) |
150 mg
(n=16) |
(n=16) |
(n=79) |
| Age (years) |
|
|
|
|
|
|
|
|
|
|
|
|
| Mean±SD |
35.0 ± 8.5 |
31.5 ± 8.3 |
26.2 ± 4.6 |
27.5 ± 7.6 |
28.5 ± 5.6 |
27.0 ± 4.7 |
23.6 ± 4.0 |
24.3 ± 3.3 |
27.5 ± 9.0 |
27.6 ± 7.2 |
27.9 ± 6.9 |
27.4 ± 6.5 |
| Sex, n (%) |
|
|
|
|
|
|
|
|
|
|
|
|
| Male |
23 (96) |
6 (100) |
6 (100) |
6 (100) |
6 (100) |
6 (100) |
5 (100) |
6 (100) |
6 (100) |
16 (100) |
16 (100) |
79 (100) |
Ethnic origin,
n (%) |
|
|
|
|
|
|
|
|
|
|
|
|
| Black |
13 (54) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
| Other |
6 (25) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
| Caucasian |
5 (21) |
6 (100) |
6 (100) |
6(100) |
6 (100) |
6 (100) |
5 (100) |
6 (100) |
6 (100) |
16 (100) |
16 (100) |
79 (100) |
| Weight (kg) |
|
|
|
|
|
|
|
|
|
|
|
|
| Mean±SD |
80 ± 11 |
76.7 ± 7.5 |
72.8 ± 11.2 |
73.8 ± 8.2 |
70.3 ± 6.7 |
72.0 ± 6.4 |
72.2 ± 7.4 |
72.8 ± 6.8 |
77.5 ± 7.7 |
72.3 ± 8.3 |
74.8 ± 10.6 |
73.6 ± 8.4 |
| Study 3. Multiple-Ascending-Dose Study |
| |
Desvenlafaxine |
Placebo |
Total |
300 mg
(n=9) |
450 mg
(n=9) |
600 mg
(n=9) |
(n=9) |
(n=36) |
| Age (years) |
|
|
|
|
|
| Mean±SD |
34.0 ± 5.4 |
34.9 ± 7.4 |
32.9 ± 4.7 |
34.7 ± 6.6 |
34.1 ± 5.9 |
| Sex, n (%) |
|
|
|
|
|
| Male |
9 (100) |
9 (100) |
9 (100) |
9 (100) |
36 (100) |
Ethnic origin,
n (%) |
|
|
|
|
|
| Black |
3 (33) |
8 (89) |
2 (22) |
3 (33) |
16 (44) |
| Other |
1 (11) |
1 (11) |
3 (33) |
1 (11) |
6 (17) |
| Caucasian |
5 (56) |
0 |
4 (44) |
5 (56) |
14 (39) |
| Weight (kg) |
|
|
|
|
|
| Mean±SD |
83.0 ± 10.3 |
80.8 ± 10.1 |
79.6 ± 13.3 |
81.7 ± 6.3 |
81.3 ± 9.9 |
ER, extended release; SD, standard deviation |
