Clinical Trials Directory

Trials / Completed

CompletedNCT00426036

Effect of Severe Renal Impairment on Pharmacokinetics and Metabolism of a Single Administration of Licarbazepine

An Open-Label Study in Healthy Subjects and in Patients With Stable Impaired Renal Function to Assess the Effect of Severe Renal Impairment on Licarbazepine Pharmacokinetics and Metabolism After the Single Administration of a 500 mg Licarbazepine Immediate Release (IR) Tablet

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
12 (planned)
Sponsor
Novartis · Industry
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

This study will assess the influence of severe renal impairment on the pharmacokinetics of licarbazepine and its glucuronide conjugate after single oral administration in healthy subjects and in subjects with stable impaired renal function.

Conditions

Interventions

TypeNameDescription
DRUGLicarbazepine

Timeline

Start date
2006-06-01
First posted
2007-01-24
Last updated
2007-06-22

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT00426036. Inclusion in this directory is not an endorsement.

Effect of Severe Renal Impairment on Pharmacokinetics and Metabolism of a Single Administration of Licarbazepine (NCT00426036) · Clinical Trials Directory