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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00840099
First received: February 6, 2009
Last updated: July 8, 2009
Last verified: July 2009
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-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 Fasting 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 fed
Active Comparator: 2 Drug: Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension
1 x 600 mg/42.9 mg/5 mL, single-dose fed

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, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840099

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 Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00840099     History of Changes
Other Study ID Numbers: 02-543
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 July 26, 2014