Status:
COMPLETED
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions
Lead Sponsor:
Teva Pharmaceuticals USA
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2002
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00840099
Start Date
August 1 2002
End Date
August 1 2002
Last Update
August 20 2024
Active Locations (1)
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1
Pharma Medica Research Inc.
Toronto, Ontario, Canada, M1R 5A3