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

Phase 1

Completed

Conditions: Healthy

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

Registration Number: NCT00840099

Lead Sponsor: Teva Pharmaceuticals USA

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.

Detailed Description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension	-
1	600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL	-

Primary Outcome Measures

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