Levetiracetam 750 mg Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Levetiracetam; Keppra®
Intervention description: 750 mg Tablet; 750 mg Tablet
Intervention MeSH terms: Levetiracetam
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

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.
    

Eligibility criteria:

        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.