HealthyPhase 1NCT00849862

Levetiracetam 750 mg Tablets Under Fasting Conditions

A Phase 1 study testing Levetiracetam and Keppra® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to compare the rate and extent of absorption of a test formulation of Levetiracetam and the reference Keppra® administered as a 1 x 750 mg tablet under fasting conditions. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Levetiracetam and Keppra®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteCanada
Study dates: Oct 2005to Nov 2005
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or Female, smoker or non-smoker, between the ages of 18 years and 55 years.
BMI greater than or equal to 19.0 and less than 30.0 kg/m2.

Who cannot join

Subjects to whom any of the following applies will be excluded from the study:
Clinically significant illnesses or surgery within 4 weeks of the administration of study medication.
Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
Positive testing for hepatitis B, hepatitis C or HIV at screening.
ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90; or heart rate less than 50 bpm or over 100 bpm) at screening.

Show all 27Show fewer

History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer or 45 mL of 40% alcohol]), or positive alcohol breath test at screening.
Use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit or positive urine drug screen at screening.
History of allergic reactions to heparin, levetiracetam, or other related drugs.
Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants, cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to the administration of the study medication.
Use of an investigational drug or participation in an investigational study within 30 days prior to dosing.
Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug.
Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products) including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
Difficulty to swallow study medication.
Smoking more than 25 cigarettes per day.
Any food allergy, intolerance, restriction, or special diet, that, in the opinion of the Medical Sub-Investigator could contraindicate the subject's participation in this study.
A depot injection or an implant of an drug within 6 months prior to administration of study medication.
Donation of plasma (500 mL) within 30 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
50 mL to 500 mL of whole blood within 30 days
more than 500 mL of whole blood within 56 days.+
Difficulty fasting or consuming the standard meals.
Intolerance to venipunctures.
Clinically significant history of renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
Positive urine pregnancy test at screening.
Breast feeding subjects.

Trial locations and contacts

1 site in 1 country.

Canada1 site

SFBC-Anapharm
Sainte-Foy, Quebec, G1V 2K8

Other trials in Canada

About this study

Official title: Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Levetiracetam 750 mg Tablet and Keppra® (Reference) Following a 750 mg Dose in Healthy Subjects Under Fasting Conditions

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions: Healthy
Being tested: Levetiracetam, Keppra®
Keywords: Bioequivalence, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LevetiracetamDrug
750 mg Tablet
Keppra®Drug
750 mg Tablet

Study groups in NCT00849862
Study group	Role	What they receive
Levetiracetam	Experimental	Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period Receives: Drug: Levetiracetam
Keppra®	Active comparator	Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period Receives: Drug: Keppra®

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax - Maximum Observed Concentration
Bioequivalence based on Cmax
Measured: Blood samples collected over 36 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Bioequivalence based on AUC0-inf
Measured: Blood samples collected over 36 hour period
AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Bioequivalence based on AUC0-t
Measured: Blood samples collected over 36 hour period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005Nov 2005

First posted24 Feb 2009 (estimated)
Study startOct 2005
Primary completionNov 2005
Study completionNov 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00849862
Sponsor's protocol ID: 50276
Status last verified: Sep 2009
First submitted: 20 Feb 2009
Last updated: 11 Sep 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Levetiracetam 750 mg Tablet and Keppra® (Reference) Following a 750 mg Dose in Healthy Subjects Under Fasting Conditions
ClinicalTrials.gov ID: NCT00849862
Acronym / sponsor ID: 50276
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Nov 2005 (actual)
Study completion: Nov 2005 (actual)
First posted: 24 Feb 2009 (estimated)
Results: Posted 4 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Levetiracetam	Experimental	Drug: LevetiracetamLevetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
Keppra®	Active comparator	Drug: Keppra®Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Male or Female, smoker or non-smoker, between the ages of 18 years and 55 years.
BMI greater than or equal to 19.0 and less than 30.0 kg/m2.

Key exclusion criteria (27 listed)

Clinically significant illnesses or surgery within 4 weeks of the administration of study medication.
Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
Positive testing for hepatitis B, hepatitis C or HIV at screening.
ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90; or heart rate less than 50 bpm or over 100 bpm) at screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Levetiracetam750 mg Tablet	Drug	Levetiracetam
Keppra®750 mg Tablet	Drug	Keppra®

Primary outcome

Cmax - Maximum Observed Concentration
Time frame: Blood samples collected over 36 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time frame: Blood samples collected over 36 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Time frame: Blood samples collected over 36 hour period
Bioequivalence based on AUC0-t

Results and safety

Results posted to the registry on 4 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Levetiracetam (Test) First	11	11
Keppra® (Reference) First	11	11

Primary outcome: Cmax - Maximum Observed Concentration

Time frame: Blood samples collected over 36 hour period. Mean (Standard Deviation). Unit: mcg/mL

Measure	Levetiracetam n = 22	Keppra® n = 22
Value	21.625 (5.699)	23.501 (6.247)

Levetiracetam vs Keppra®: Geometric Test/Ref Ratio x 100: 92.2 (90% CI 85.0 to 100)

Population analysed: Data from all subjects who completed the study were included in the statistical analysis.

Primary outcome: AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Time frame: Blood samples collected over 36 hour period. Mean (Standard Deviation). Unit: mcg*h/mL

Measure	Levetiracetam n = 22	Keppra® n = 22
Value	186.097 (35.240)	185.293 (29.845)

Levetiracetam vs Keppra®: Geometric Test/Ref Ratio x 100: 100 (90% CI 96.3 to 104)

Population analysed: Data from all subjects who completed the study were included in the statistical analysis.

Primary outcome: AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Time frame: Blood samples collected over 36 hour period. Mean (Standard Deviation). Unit: mcg*h/mL

Measure	Levetiracetam n = 22	Keppra® n = 22
Value	173.932 (33.436)	174.275 (31.177)

Levetiracetam vs Keppra®: Geometric Test/Ref Ratio x 100: 99.6 (90% CI 96.2 to 103)

Population analysed: Data from all subjects who completed the study were included in the statistical analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Larouche, MD principal investigator

SFBC Anapharm

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Levetiracetam and Keppra® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax - Maximum Observed Concentration (time frame: Blood samples collected over 36 hour period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00849862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2009.