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Pharmacokinetics and Tolerability of Sulthiame

NCT03400189 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-02-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sulthiame

Single dose (50, 100, 200 mg)

Sponsors & Collaborators

  • Advicenne Pharma

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2018-05-22
Completion
2018-08-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03400189 on ClinicalTrials.gov