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

NCT00840099 | Completed Phase 1 Results

• 1 other identifier: 02-543
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL

2

ACTIVE COMPARATOR

Drug: Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension

Interventions

600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL DRUG

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

1

Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Pharma Medica Research Inc.

Toronto, Ontario, M1R 5A3, Canada

Location

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination; Suspensions

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Colloids; Complex Mixtures; Dosage Forms

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Xueyu (Eric) Chen, M.D., Ph. D.

  Pharma Medica Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 10, 2009
• Study Start: August 1, 2002
• Primary Completion: August 1, 2002
• Study Completion: August 1, 2002
• Last Updated: August 20, 2024
• Results First Posted: August 25, 2009

Record last verified: 2024-08

Locations

CA (1)