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

Study Overview
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Brief Summary
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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.

Detailed Description
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Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL
* Drug: Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL<br>* 1 x 600 mg/42.9 mg/5 mL, single-dose fed<br>|
| Active Comparator: 2<br> | Drug: Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension<br>* 1 x 600 mg/42.9 mg/5 mL, single-dose fed<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Healthy Subjects