600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions

An Open-Label, Single-Dose, Two-Way Crossover Bioequivalence Study of Two Oral Suspension Formulations of Amoxicillin/Clavulanate Potassium, 600/42.9 mg/5 mL in Healthy Subjects Under Fasting Conditions

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.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

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.