Table 1.
Summary of the subject characteristics and the variables of the data set relevant for the model development across the three studies
| Study I | Study II | Study III | Total | |
|---|---|---|---|---|
| Number of subjects | 12 | 11 | 9 | 32 |
| Number of PK observations | ||||
| IV TPM | 155 | – | – | 155 |
| Oral TPM | 159 | 11 | 9 | 179 |
| Number of PD observations | ||||
| Pretreatment | 9 | 11 | 9 | 29 |
| IV TPM | 30 | – | – | 30 |
| Oral TPM | 30 | 11 | 9 | 50 |
| Placebo | – | 11 | 9 | 20 |
| Post-treatment | 8 | 11 | 8 | 27 |
| Bodyweight (kg) | 78.24 ± 16.3 | 79.06 ± 13.69 | 71.2 ± 11.74 | 76.54 ± 14.21 |
| 76.9 (58.3–112.3) | 78.76 (59.78–111.22) | 72.27 (54.73–92.27) | 77.27 (54.73–112.30) | |
| Age (years) | 35 ± 13.27 | 33.64 ± 11.07 | 21.78 ± 1.56 | 30.81 ± 11.66 |
| 31.5 (19–55) | 31 (20–50) | 22 (20–24) | 26.5 (19–55) | |
| Sex | ||||
| Men/women | 6/6 | 7/4 | 7/2 | 20/12 |
| Race | ||||
| Caucasian/AA/other/unknown | 11/1/0/0 | 7/3/0/1 | 6/1/2/0 | 24/5/2/1 |
Values are count, mean ± SD or median (range). Abbreviations are as follows: AA, African American; IV, intravenous; PD, pharmacodynamics; PK, pharmacokinetics; TPM, topiramate.