Overview

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

Status:
Completed
Trial end date:
2002-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Teva Pharmaceuticals USA
Treatments:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acid
Clavulanic Acids
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.