Table 1.
Study | Treatment | Formulation | Dose (mg/kg) | With water | Fast or fed | Crush tablets | Number of subjects |
---|---|---|---|---|---|---|---|
200585-001 | A | Racemic ODT | 40 | Water | Food | No | 31 |
B | Current formulation | 40 | Water | Food | No | 31 | |
C1 | Racemic ODT | 20 | Water | Food | No | 14 | |
C2 | Racemic ODT | 60 | Water | Food | No | 15 | |
D1 | Racemic ODT | 40 | Water | Fasting | No | 14 | |
D2 | Current ODT | 40 | Water | Food | Yes | 14 | |
200661-001 | A | L-PZQ ODT | 20 | Water | Food | No | 36 |
B | Current formulation | 40 | Water | Food | No | 36 | |
C1 | L-PZQ ODT | 10 | Water | Food | No | 17 | |
C2 | L-PZQ ODT | 30 | Water | Food | No | 17 | |
D | L-PZQ ODT | 20 | Water | Fast | No | 35 | |
E | L-PZQ ODT | 20 | – | Food | No | 36 |