drugset / Trial / NCT03400189
Pharmacokinetics and Tolerability of Sulthiame
NaSingle-groupOpen-labelOther
Summary
This preliminary pilot exploration aims at specifying the pharmacokinetic parameters of sulthiame, formulated as an immediate release tablet, thus helping to design proper clinical trials for the future assessment of new paediatric formulations currently under development. The clinical tolerability to single doses of sulthiame will also be closely monitored to orient future trials.
Timeline
- Start
- 2018-02-12
- Primary completion
- 2018-05-22
- Completion
- 2018-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sulthiame | Small molecule | 50 mg | Oral |
| Subject | Sulthiame | Small molecule | 100 mg | Oral |
| Subject | Sulthiame | Small molecule | 200 mg | Oral |