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Amoxicillin-Clavulanic Acid 400 mg-57 mg Chewable Tablets Under Fasting 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: amoxicillin-clavulanic acid (Drug); Augmentin® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Benoit Girard, MD, Principal Investigator, Affiliation: Anapharm

Summary

The objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under fasting conditions.

Clinical Details

Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 400 mg-57 mg Chewable Tablets and AUGMENTIN® 400 mg-57 mg Chewable Tablets Administered as 1 x 400 mg-57 mg Chewable Tablet in Healthy Subjects Under Fasting Conditions

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

Primary outcome:

Cmax (Maximum Observed Concentration) - Amoxicillin

AUC0-Inf - [Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin

AUC0-t [Area Under the Concentration-Time Curve From Time Zero to Time of Last Non-Zero Concentration (Per Participant)] - Amoxicillin

Cmax (Maximum Observed Concentration) - Clavulanic Acid

AUC0-Inf [Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated)] - Clavulanic Acid

AUC0-t [Area Under the Concentration-Time Curve From Time Zero to Time of Last Non-Zero Concentration (Per Participant)] - 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

- Subjects will be females and/or males, non-smokers, 18 years of age and older.

Exclusion Criteria Subjects to whom any of the following applies will be excluded from the study:

- Clinically significant illnesses within 4 weeks of the administration of study

medication.

- Clinically significant surgery within 4 weeks prior to the administration of the

study medication.

- Any clinically significant abnormality found during medical screening.

- Any reason which, in the opinion of the medical subinvestigator, would prevent the

subject from participating in the study.

- Abnormal laboratory tests judged clinically significant.

- Positive urine drug screen at screening.

- Positive testing for hepatitis B, hepatitis C or HIV at screening.

- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic

blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90; or heart rate less than 50 bpm) at screening.

- Subjects with BMI ≥30. 0.

- History of significant alcohol abuse within six months of the screening visit or any

indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).

- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana)

within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.

- Any food allergy, intolerance, restriction or special diet that, in the opinion of

the medical subinvestigator, contraindicates the subject's participation in this study.

- History of allergic or hypersensitivity reactions to amoxicillin or clavulanic acid

or other related drugs (e. g. penicillin, cephalosporins, cephamycins).

- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of

inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine, valproic acid)

- use of an investigational drug or participation on an investigation study within 30

days prior to the administration of the study medication.

- Clinically significant history or presence of any clinically significant

gastrointestinal pathology (e. g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e. g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.

- Any clinically significant history or presence of clinically significant

neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.

- Any food allergy, intolerance, restriction or special diet that could, in the opinion

of the Medical Subinvestigator, contraindicate the subject's participation in this study.

- Use of prescription medication within 14 days prior to administration of study

medication or over-the-counter products )including natural products, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.

- Subjects who have had a depot injection or an implant of any drug 3 months prior to

administration of study medication.

- Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to

administration of the study medication as follows:

- Less than 300 mL of whole blood within 30 days or

- 300 mL to 500 mL of whole blood within 45 days or

- more than 500 mL of whole blood within 56 days.

- Positive alcohol breath test at screening.

- Subjects who have used tobacco in any form within the 90 days preceding study drug

administration.

- Intolerance to venipunctures

- Subjects with a clinically significant history of tuberculosis, epilepsy, asthma,

diabetes, psychosis, or glaucoma will not be eligible for this study.

- Any history of known Augmentin-associated cholestatic jaundice/hepatic dysfunction

- Any known active mononucleosis

- Subjects with dentures or braces.

Additional exclusion criteria for female subjects only:

- Breast feeding subjects.

- Positive urine pregnancy test at screening (performed on all females).

Locations and Contacts

Anapharm Inc., Sainte-Foy, Quebec G1V 2K8, Canada
Additional Information

Starting date: September 2003
Last updated: July 6, 2009

Page last updated: August 23, 2015

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