600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions
Condition: Healthy
Intervention: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL; Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension
Intervention description: 1 x 600 mg/42.9 mg/5 mL, single-dose fed; 1 x 600 mg/42.9 mg/5 mL, single-dose fed
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this study is to assess the bioequivalence between Amoxicillin and
      Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral
      Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, non-smoking male or non-pregnant, non-lactating female subjects, 18 years of
             age and over.

          -  Body weight within ±15% of the appropriate weight range published in 1993 by
             Metropolitan Life Insurance Company, Statistical Bureau and body-mass index (BMI) less
             than 30.

          -  Negative for:

               -  HIV

               -  Hepatitis B and C

               -  Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine,
                  opiates, benzodiazepines and methadone).

               -  Cotinine (urine test)

               -  Breath alcohol (Breathalyzer)

               -  HCG (females only)

          -  No significant diseases or clinically significant abnormal laboratory values.

          -  No clinically significant findings in the physical examination.

          -  No clinically significant findings in vital sign measurements and 12-lead
             electrocardiogram (ECG).

          -  Informed of the nature of the study and give written consent prior to receiving any
             study medication.

          -  Female subjects: surgically steril, post-menopausal or practicing a recognized safe
             method of contraception (abstention, oral or implanted contraceptives, intra-uterine
             device or consistent condom plus spermicide use).

        Exclusion Criteria:

          -  Known history or presence of any disease or condition which might compromise the
             following body systems: immunologic, endocrine, renal, cardiovascular, respiratory,
             hematologic, gastrointestinal, neurologic, hepatic, psychiatric or dermatologic

          -  More specifically: history or presence of significant: sensitivity to multiple
             allergens, diarrhea, stomach or intestinal disease, mononucleosis, renal or hepatic
             dysfunction and asthma.

          -  Known or suspected carcinoma.

          -  Known history or presence of:

               -  Hypersensitivity or idiosyncratic reaction to amoxicillin, clavulanic acid,
                  penicillins, cephalosporins and/or any other β-lactamase inhibitors.

               -  Clavulin-associated jaundice/hepatic dysfunction.

               -  Alcoholism within last 12 months.

               -  Drug dependence and/or substance abuse.

               -  Use of tobacco or nicotine-containing products, within last 12 months.

          -  On a special diet within 4 weeks prior to drug administration (i.e. a deliberate
             change in diet for any reason).

          -  Participation in another clinical trial or received an investigational product in the
             previous 30 days prior to drug administration.

          -  Donation up to 250 mK of blood in the previous 30 days, 251-500 mKL in the previous 45
             days, 501-750 mL in the previous 60 days or above 750 mL in the previous 90 days prior
             to study start.

          -  Requirement of any medication, (prescription and/or over-the-counter) or dietary
             supplements on a routine basis, with the exception of occasional use of acetaminophen
             and oral or implanted contraceptives.

          -  Difficulty fasting or consuming the standard prescribed meals.