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

February 6, 2009
July 8, 2009
August 2002
August 2002   (final data collection date for primary outcome measure)
  • 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 ]
Bioequivalence based on Cmax and AUC [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00840840 on ClinicalTrials.gov Archive Site
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600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions
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

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.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL
    1 x 600 mg/42.9 mg/5 mL, single-dose fasting
  • Drug: Augmentin ES-600™
    1 x 600 mg/42.9 mg/5 mL, single-dose fasting
  • Experimental: 1
    Intervention: Drug: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL
  • Active Comparator: 2
    Intervention: Drug: Augmentin ES-600™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
August 2002
August 2002   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00840840
02-544
No
Not Provided
Teva Pharmaceuticals USA
Not Provided
Principal Investigator: Xueyu (Eric) Chen, M.D., Ph.D. Pharma Medica Research
Teva Pharmaceuticals USA
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP