CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Levetiracetam 250 mg +1 moredrug
Likely dose
Levetiracetam 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01491113
NCT01491113Phase 4Completed
CompareCT.gov

Single-Dose Pharmacokinetics of Orally Administered Levetiracetam (LEV) in Japanese Subjects With Normal Renal Function and Various Degrees of Renal Impairment Using a Dosing Regimen Adjusted to Renal Function (250 mg or 500 mg)

UCB Pharma·interventional·Posted Dec 13, 2011·Updated Feb 10, 2014

In Brief

A Phase 4 clinical trial evaluating Levetiracetam 250 mg and Levetiracetam 500 mg for Healthy Subjects and Renal Impairments. Completed, enrolled 30 participants across 2 sites.

Detailed Summary

This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in Japanese subjects with various degrees of impaired renal function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects, Renal Impairments
CountriesJapan
CollaboratorsParexel

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 13, 2011
Enrollment StartNov 1, 2011
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.6 years ago

Interventions

Levetiracetam 250 mgdrug

Tablet containing Levetiracetam 250 mg

Levetiracetam 500 mgdrug

Tablet containing Levetiracetam 500 mg