The purpose of this study is to assess the bioequivalence between Amoxicillin/Clavulanate
Potassium Oral Suspension 600/42. 9 mg/5 mL and Augmentin ES-600 Oral Suspension, 600/42. 9
mg/5 mL in healthy, male and female subjects, under fed conditions.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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,
penicillin, 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.