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

NCT ID: NCT00840840

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2002-08-31

Brief 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.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL

Intervention Type: DRUG

1 x 600 mg/42.9 mg/5 mL, single-dose fasting

2

Group Type: ACTIVE_COMPARATOR

Augmentin ES-600™

Intervention Type: DRUG

1 x 600 mg/42.9 mg/5 mL, single-dose fasting

Interventions

600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL

1 x 600 mg/42.9 mg/5 mL, single-dose fasting

Intervention Type: DRUG

Augmentin ES-600™

1 x 600 mg/42.9 mg/5 mL, single-dose fasting

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Xueyu (Eric) Chen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pharma Medica Research

Locations

Pharma Medica Research Inc.

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

02-544

Identifier Type: -

Identifier Source: org_study_id