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Levetiracetam 750 mg Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00849862
Recruitment Status : Completed
First Posted : February 24, 2009
Results First Posted : August 4, 2009
Last Update Posted : September 11, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE February 20, 2009
First Posted Date  ICMJE February 24, 2009
Results First Submitted Date  ICMJE June 30, 2009
Results First Posted Date  ICMJE August 4, 2009
Last Update Posted Date September 11, 2009
Study Start Date  ICMJE October 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2009)
  • 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 Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 36 hour period ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2009)
Bioequivalence based on Cmax and AUC [ Time Frame: 2 weeks ]
Change History Complete list of historical versions of study NCT00849862 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Levetiracetam 750 mg Tablets Under Fasting Conditions
Official Title  ICMJE 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
Brief 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.
Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Levetiracetam
    750 mg Tablet
  • Drug: Keppra®
    750 mg Tablet
Study Arms  ICMJE
  • Experimental: Levetiracetam
    Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
    Intervention: Drug: Levetiracetam
  • Active Comparator: Keppra®
    Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
    Intervention: Drug: Keppra®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2009)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • 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.

Exclusion Criteria

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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00849862
Other Study ID Numbers  ICMJE 50276
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Teva Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Larouche, MD SFBC Anapharm
PRS Account Teva Pharmaceuticals USA
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP