NCT00946751

Brief Summary

To demonstrate the relative bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam tablets in healthy adult volunteers under fasting conditions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2004

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

March 1, 2004

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

March 28, 2017

Status Verified

July 1, 2009

Enrollment Period

Same day

First QC Date

July 24, 2009

Last Update Submit

March 27, 2017

Conditions

Seizure

Keywords

Anticonvulsant

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    10 days

Study Arms (2)

1

EXPERIMENTAL

Levetiracetam Tablets, 750 mg (Sandoz Inc.)

Drug: Levetiracetam Tablets, 750 mg (Sandoz Inc.)

2

ACTIVE COMPARATOR

Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)

Drug: Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)

Interventions

Levetiracetam Tablets, 750 mg (Sandoz Inc.)DRUG
1
Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)DRUG
2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Seizures

Interventions

LevetiracetamTablets

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • Gaetano Morelli, M.D.

    MDS Pharma Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

March 1, 2004

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

March 28, 2017

Record last verified: 2009-07