Amoxicillin-Clavulanic Acid 400 mg-57 mg Chewable Tablets Under Fasting Conditions
Condition: Healthy
Intervention: amoxicillin-clavulanic acid; Augmentin®
Intervention description: 400 mg-57 mg chewable tablet; 400 mg-57 mg chewable tablet
Intervention MeSH terms: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Clavulanic Acid
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 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
      amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin®
      (reference) administered as 1 x 400 mg-57 mg chewable tablet under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria

          -  Subjects will be females and/or males, non-smokers, 18 years of age and older.

        Exclusion Criteria

        Subjects to whom any of the following applies will be excluded from the study:

          -  Clinically significant illnesses within 4 weeks of the administration of study
             medication.

          -  Clinically significant surgery within 4 weeks prior to the administration of the study
             medication.

          -  Any clinically significant abnormality found during medical screening.

          -  Any reason which, in the opinion of the medical subinvestigator, would prevent the
             subject from participating in the study.

          -  Abnormal laboratory tests judged clinically significant.

          -  Positive urine drug screen at screening.

          -  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) at screening.

          -  Subjects with BMI ≥30.0.

          -  History of significant alcohol abuse within six months of the screening visit or any
             indication of the regular use of more than two units of alcohol per day (1 Unit = 150
             mL of wine or 360 mL of beer or 45 mL of alcohol 40%).

          -  History of drug abuse or use of illegal drugs: 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.

          -  Any food allergy, intolerance, restriction or special diet that, in the opinion of the
             medical subinvestigator, contraindicates the subject's participation in this study.

          -  History of allergic or hypersensitivity reactions to amoxicillin or clavulanic acid or
             other related drugs (e.g. penicillin, cephalosporins, cephamycins).

          -  Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of
             inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin;
             examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin,
             ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine, valproic acid)

          -  use of an investigational drug or participation on an investigation study within 30
             days prior to the administration of the study medication.

          -  Clinically significant history or presence of any clinically significant
             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 clinically significant neurological,
             endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or
             metabolic disease.

          -  Any food allergy, intolerance, restriction or special diet that could, in the opinion
             of the Medical Subinvestigator, contraindicate the subject's participation in this
             study.

          -  Use of prescription medication within 14 days prior to administration of study
             medication or over-the-counter products )including natural products, vitamins, garlic
             as a supplement) within 7 days prior to administration of study medication, except for
             topical products without systemic absorption.

          -  Subjects who have had a depot injection or an implant of any drug 3 months prior to
             administration of study medication.

          -  Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to
             administration of the study medication as follows:

          -  Less than 300 mL of whole blood within 30 days or

          -  300 mL to 500 mL of whole blood within 45 days or

          -  more than 500 mL of whole blood within 56 days.

          -  Positive alcohol breath test at screening.

          -  Subjects who have used tobacco in any form within the 90 days preceding study drug
             administration.

          -  Intolerance to venipunctures

          -  Subjects with a clinically significant history of tuberculosis, epilepsy, asthma,
             diabetes, psychosis, or glaucoma will not be eligible for this study.

          -  Any history of known Augmentin-associated cholestatic jaundice/hepatic dysfunction

          -  Any known active mononucleosis

          -  Subjects with dentures or braces.

        Additional exclusion criteria for female subjects only:

          -  Breast feeding subjects.

          -  Positive urine pregnancy test at screening (performed on all females).