NCT00826722

Brief Summary

The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets under fasted conditions

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

January 15, 2009

Last Update Submit

January 19, 2018

Conditions

Seizures

Outcome Measures

Primary Outcomes (1)

  • bioequivalence based on Cmax

    10 days

Interventions

LevetiracetamDRUG

1000 mg tablet

Also known as: KEPPRA

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

You may not qualify if:

  • Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novum Pharmaceutical Research Services

Houston, Texas, 77042, United States

Location

MeSH Terms

Conditions

Seizures

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Soran Hong, MD

    Novum Pharmaceutical Research Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 22, 2009

Study Start

June 1, 2007

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)