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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL; Drug: Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M1R 5A3
      • Pharma Medica Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioequivalence Based on Cmax for Amoxicillin	Cmax - Maximum Observed Concentration	Blood samples collected over 14 hour period
Bioequivalence Based on AUC0-inf for Amoxicillin	AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)	Blood samples collected over 14 hour period
Bioequivalence Based on AUC0-t for Amoxicillin	AUC0-t - Area under the concentration-time curve from time zero to the time of last non-zero concentration	Blood samples collected over 14 hour period
Bioequivalence Based on Cmax for Clavulanic Acid	Cmax - Maximum Observed Concentration	Blood samples collected over 14 hour period
Bioequivalence Based on AUC0-inf for Clavulanic Acid	AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)	Blood samples collected over 14 hour period
Bioequivalence Based on AUC0-t for Clavulanic Acid	AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration	Blood samples collected over 14 hour period

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: Xueyu (Eric) Chen, M.D., Ph. D., Pharma Medica Research, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): August 1, 2002
• Study Completion (Actual): August 1, 2002

Study Registration Dates

• First Submitted: February 6, 2009
• First Submitted That Met QC Criteria: February 9, 2009
• First Posted (Estimated): February 10, 2009

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: 02-543