drugset / Trial / NCT03400189

Pharmacokinetics and Tolerability of Sulthiame

NCT03400189

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

EvaluationDrugModalityDoseRoute
Subject Sulthiame Small molecule 50 mg Oral
Subject Sulthiame Small molecule 100 mg Oral
Subject Sulthiame Small molecule 200 mg Oral

Indications