TABLE 5.
Plasma concentrations of OPT-80 and the primary metabolite, OP-1118
| Drug and OPT-80 treatment | Total no. of subjectsa | No. of subjects with the following plasma drug concn:
|
Top concn found (ng/ml)b | |||
|---|---|---|---|---|---|---|
| <5 ng/ml | 5-20 ng/ml | 20-100 ng/ml | >100 ng/ml | |||
| OPT-80 | ||||||
| 100 mg/day | 14 | 12 | 2 | 0 | 0 | 12.3 |
| 200 mg/day | 16 | 7 | 8 | 1 | 0 | 93.7 |
| 400 mg/day | 16 | 3 | 11 | 2 | 0 | 84.9 |
| OP-1118 | ||||||
| 100 mg/day | 14 | 1 | 11 | 2 | 0 | 77.2 |
| 200 mg/day | 16 | 2 | 8 | 5 | 1 | 154.3 |
| 400 mg/day | 16 | 0 | 7 | 9 | 1 | 402.3 |
a
Number of subjects with at least one plasma pharmacokinetic sample collected after the first dose.
b
The highest concentration found in any subject within the dosing group.