Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Levetiracetam 1000 mg Under Non-Fasting Conditions

This study has been completed.
Information provided by:
Teva Pharmaceuticals USA Identifier:
First received: March 9, 2009
Last updated: July 9, 2009
Last verified: July 2009
The objective of this study is to compare the rate and extent of absorption of an investigational formulation of levetiracetam 1000 mg tablet to an equivalent oral dose of the commercially available reference product under fed conditions.

Condition Intervention Phase
Drug: Levetiracetam
Drug: Keppra®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Levetiracetam 1000 mg Tablet Under Fed Conditions

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 36 hour period ]
  • AUC0-Inf - Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 36 hour period ]
  • AUC0-t - Area Under the Concentration-Time Curve From Time Zero to Time of Last Non-Zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 36 hour period ]

Enrollment: 22
Study Start Date: January 2007
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam
Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
Drug: Levetiracetam
1000 mg Tablet
Active Comparator: Keppra®
Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
Drug: Keppra®
1000 mg Tablet

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

All subjects must satisfy the following criteria to be considered for study participation:

  • Subject must be male or non-pregnant, non-breast-feeding female
  • Subject must be at least 18 years of age
  • Subject must have a Body Mass Index (BMI) between 19 and 30 kg/m2, inclusive, and body weight should be at least 50 kg (110 lbs)
  • Female Subjects - not surgically sterile or at least two years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, double barrier (condom with spermicide, diaphragm with spermicide), intra-uterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).
  • Subject must voluntarily consent to participate in this study and provide their written informed consent prior to the start of any study-specific procedures.
  • Subject is willing and able to consume the entire high-calorie, high-fat breakfast meal in the designated timeframe required during each study period.
  • Subject is willing and able to remain in the study unit for the entire duration of each confinement period and return for any outpatient visits.

Exclusion Criteria

Subjects may be excluded for any of the following:

  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
  • Has a clinically significant abnormal finding on the physical exam, medical history, ECG or clinical laboratory results at screening.
  • History or presence of allergic or adverse response to levetiracetam or related drugs.
  • Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
  • Has donated blood or plasma within 30 days prior to the first dose of study medication.
  • Has participated in another clinical trial within 30 days prior to the first dose of study medication.
  • Has used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication.
  • Has used any prescription medication, including hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
  • Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
  • Has smoked or used tobacco products within 90 days prior to the first dose of study medication.
  • Subject has consumed alcohol, caffeine/xanthine, or grapefruit containing beverages and foods from 48 hours prior to the dose of study medication and throughout the sample collection period.
  • Is a female with a positive pregnancy test result.
  • Female who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study start.
  • Has an intolerance to venipuncture.
  • Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates)
  • Has a history of drug or alcohol abuse.
  • Has had a positive test for, or has been treated for hepatitis B, hepatitis C or HIV.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00859430

United States, Texas
CEDRA Clinical Research, LLC
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Teva Pharmaceuticals USA
Principal Investigator: James P Doherty, D.O. CEDRA
  More Information Identifier: NCT00859430     History of Changes
Other Study ID Numbers: 20-117-SA
Study First Received: March 9, 2009
Results First Received: July 9, 2009
Last Updated: July 9, 2009

Keywords provided by Teva Pharmaceuticals USA:
Healthy Subjects

Additional relevant MeSH terms:
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs processed this record on May 25, 2017