drugset / Trial / NCT04283136
A Study to Test the Blood Concentration of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil
RandomizedCrossoverOpen-labelBasic science
Summary
The purpose of the study in Part 1, is to evaluate (under fasted conditions) the plasma pharmacokinetics (PK) of padsevonil (PSL) using 4 PSL product variants against a PSL reference tablet and in Part 2, to evaluate the PK of PSL using a PSL reference tablet under fed and fasted conditions at 200 mg and 400 mg.
Timeline
- Start
- 2020-02-24
- Primary completion
- 2020-05-22
- Completion
- 2020-05-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Padsevonil | Small molecule | 200 mg | Oral |
| Comparator | Padsevonil | Small molecule | 400 mg | Oral |