Table 1 A summary of the study data, subject demographics and covariates included in the analysis.
Characteristic | Single dose study | Drug interaction study | Food effect study | Multiple dose study | Combined |
|---|---|---|---|---|---|
No. of subjects | 28 | 19 | 20 | 24 | 91 |
No. of concentration-time profiles | 28 | 28 | 38 | 24 | 118 |
No. of observations | Â | Â | Â | Â | Â |
   AS | 206 | 207 | 324 | 179 | 916 |
   DHA | 316 | 314 | 449 | 273 | 1352 |
AS dose (mg/kg) | 2, 3, 4 or 5 | 4 | 4 | 2, 3, 4 or 5 | 2, 3, 4 or 5 |
Sampling schedule | Predose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 4, 5, 8 and 12 h postdose | Predose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 4, 5, 8 and 12 h postdose | Predose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 4, 5, 8 and 12 h postdose | Immediately prior to each dose and 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 4, 5, 8 and 12 h after the third dose | NA |
Age (years) | 24 (19-40) | 23 (20-32) | 21.5 (19-27) | 23 (19-29) | 23 (19-40) |
Weight (kg) | 62.5 (50.4-70) | 60.9 (50.1-67.1) | 59.9 (50.8-68.5) | 62.2 (51.2-68.8) | 61.5 (50.1-70) |
Sex (number) | Â | Â | Â | Â | Â |
   Female | 9 | 10 | 10 | 9 | 38 |
   Male | 19 | 9 | 10 | 15 | 53 |
Type of dosing | Single | Single | Single | Multiple (once daily for 3 days) | NA |
Food intake (number of profiles) | Â | Â | Â | Â | Â |
   Fasted | 28 | 28 | 19 | 24 | 99 |
   Fed | 0 | 0 | 19 | 0 | 19 |