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Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients

NCT01491113 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-02-10

Study results available
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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.

Conditions

  • Healthy Subjects
  • Renal Impairments

Interventions

DRUG

Levetiracetam 250 mg

Tablet containing Levetiracetam 250 mg

DRUG

Levetiracetam 500 mg

Tablet containing Levetiracetam 500 mg

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Japan

Study Locations

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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 NCT01491113 on ClinicalTrials.gov