600 mg amoxicillin/42.9 mg clavulanate postassium /5 ml suspension under fed conditions

Conditions: Healthy

Summary: 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.

criteria for evaluation: fda bioequivalence criteria statistical methods: fda bioequivalence statistical methods

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, 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.

Keywords: bioequivalence healthy subjects