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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00840840
First received: February 6, 2009
Last updated: July 8, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL
Drug: Augmentin ES-600™
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open-Label, Single-Dose, Two-Way Crossover Bioequivalence Study of Two Oral Suspension Formulations of Amoxicillin/Clavulanate Potassium, 600/42.9 mg/5 mL in Healthy Subjects, Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Bioequivalence Based on Cmax for Amoxicillin [ Time Frame: Blood samples collected over 14 hour period ] [ Designated as safety issue: No ]
  • Bioequivalence Based on AUC0-Inf for Amoxicillin [ Time Frame: Blood samples collected over 14 hour period ] [ Designated as safety issue: No ]
  • Bioequivalence Based on AUC0-t for Amoxicillin [ Time Frame: Blood samples collected over 14 hour period ] [ Designated as safety issue: No ]
  • Bioequivalence Based on Cmax for Clavulanic Acid [ Time Frame: Blood samples collected over 14 hour period ] [ Designated as safety issue: No ]
  • Bioequivalence Based on AUC0-Inf for Clavulanic Acid [ Time Frame: Blood samples collected over 14 hour period ] [ Designated as safety issue: No ]
  • Bioequivalence Based on AUC0-t for Clavulanic Acid [ Time Frame: Blood samples collected over 14 hour period ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: August 2002
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL
1 x 600 mg/42.9 mg/5 mL, single-dose fasting
Active Comparator: 2 Drug: Augmentin ES-600™
1 x 600 mg/42.9 mg/5 mL, single-dose fasting

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840840

Locations
Canada, Ontario
Pharma Medica Research Inc.
Toronto, Ontario, Canada, M1R 5A3
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Xueyu (Eric) Chen, M.D., Ph.D. Pharma Medica Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00840840     History of Changes
Other Study ID Numbers: 02-544
Study First Received: February 6, 2009
Results First Received: May 18, 2009
Last Updated: July 8, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014