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CompletedNCT00946751Updated Mar 28, 2017

To Demonstrate the Relative Bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions

A Phase 1 interventional study of Levetiracetam Tablets, 750 mg (Sandoz Inc.) and Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc) in Seizure, sponsored by Sandoz. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-28.

Sponsored by Sandoz (formerly part of Novartis) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Seizure

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Keywords

  • Anticonvulsant
03

In context

Seizures

896 studies on the registry are indexed under Seizures; 145 are open to participants now.

This study's enrollment of 20 is below the median of 62 across 621 interventional studies indexed under Seizures.

Browse Seizures studies →

Lead sponsor

Sandoz is the lead sponsor of 139 studies on the registry; none are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

First submitted before Sandoz left Novartis.

Browse Sandoz studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    1

    Levetiracetam Tablets, 750 mg (Sandoz Inc.)

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

  • Active comparator
    2

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

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

Interventions

06

What researchers measure

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 10 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2004, a primary completion of Mar 2004 and a completion of Mar 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2009
First posted
Jul 27, 2009
Start
Mar 2004
Primary completionActual
Mar 2004
CompletionActual
Mar 2004
Last update
Mar 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00946751
Lead sponsor
Sandoz
First posted
Jul 27, 2009
Start date
Mar 2004
Primary completion
Mar 2004
Completion
Mar 2004
Last update
Mar 28, 2017

Study contacts

Gaetano Morelli, M.D.
principal investigator · MDS Pharma Services
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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