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

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL (Drug); Augmentin ES-600™ (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Xueyu (Eric) Chen, M.D., Ph.D., Principal Investigator, Affiliation: Pharma Medica Research

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Bioequivalence Based on Cmax for Amoxicillin

Bioequivalence Based on AUC0-Inf for Amoxicillin

Bioequivalence Based on AUC0-t for Amoxicillin

Bioequivalence Based on Cmax for Clavulanic Acid

Bioequivalence Based on AUC0-Inf for Clavulanic Acid

Bioequivalence Based on AUC0-t for Clavulanic Acid

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

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

Starting date: August 2002
Last updated: July 8, 2009

Page last updated: August 23, 2015

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