Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting Conditions
- Conditions
- Healthy
- Registration Number
- NCT00836901
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria<br><br> - Subjects will be females and/or males, non-smokers, 18 years of age and older.<br><br>Exclusion Criteria<br><br> - Clinically significant illnesses within 4 weeks of the administration of study<br> medication.<br><br> - Clinically significant surgery within 4 weeks prior to the administration of the<br> study medication.<br><br> - Any clinically significant abnormality found during medical screening.<br><br> - Any reason which, in the opinion of the medical subinvestigator, would prevent the<br> subject from participating in the study.<br><br> - Abnormal laboratory tests judged clinically significant.<br><br> - Positive urine drug screen at screening.<br><br> - Positive testing for hepatitis B, hepatitis C or HIV at screening.<br><br> - ECG abnormalities (clinically significant) or vital sign abnormalities (systolic<br> blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower<br> than 50 or over 90; or heart rate less than 50 bpm) at screening.<br><br> - Subjects with BMI =30.0.<br><br> - History of significant alcohol abuse within six months of the screening visit or any<br> indication of the regular use of more than two units of alcohol per day (1 Unit =<br> 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).<br><br> - History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana)<br> within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine<br> (PCP) and crack) within 1 year of the screening visit.<br><br> - Any food allergy, intolerance, restriction or special diet that, in the opinion of<br> the medical subinvestigator, contraindicates the subject's participation in this<br> study.<br><br> - History of allergic or hypersensitivity reactions to amoxicillin or clavulanic acid<br> or other related drugs (e.g. penicillin, cephalosporins, cephamycins).<br><br> - Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of<br> inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids,<br> rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem,<br> erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine,<br> valproic acid) use of an investigational drug or participation on an investigation<br> study within 30 days prior to the administration of the study medication.<br><br> - Clinically significant history or presence of any clinically significant<br> gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases),<br> unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney<br> disease, or other conditions known to interfere with the absorption, distribution,<br> metabolism, or excretion of the drug.<br><br> - Any clinically significant history or presence of clinically significant<br> neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic,<br> psychiatric or metabolic disease.<br><br> - Any food allergy, intolerance, restriction or special diet that could, in the<br> opinion of the Medical Subinvestigator, contraindicate the subject's participation<br> in this study.<br><br> - Use of prescription medication within 14 days prior to administration of study<br> medication or over-the-counter products )including natural products, vitamins,<br> garlic as a supplement) within 7 days prior to administration of study medication,<br> except for topical products without systemic absorption.<br><br> - Subjects who have had a depot injection or an implant of any drug 3 months prior to<br> administration of study medication.<br><br> - Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to<br> administration of the study medication as follows:<br><br> - less than 300 mL of whole blood within 30 days, or<br><br> - 300 mL to 500 mL of whole blood within 45 days, or<br><br> - more than 500 mL of whole blood within 56 days.<br><br> - Positive alcohol breath test at screening.<br><br> - Subjects who have used tobacco in any form within the 90 days preceding study drug<br> administration.<br><br> - Intolerance to venipunctures.<br><br> - Subjects with a clinically significant history of tuberculosis, epilepsy, asthma,<br> diabetes, psychosis, or glaucoma will not be eligible for this study.<br><br> - Any history of known Augmentin-associated cholestatic jaundice/hepatic dysfunction<br><br> - Any known active mononucleosis<br><br> - Subjects with dentures or braces.<br><br>Additional exclusion criteria for female subjects only:<br><br> - Breast feeding subjects.<br><br> - Positive urine pregnancy test at screening (performed on all females).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)] - Clavunlanic Acid;AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid
- Secondary Outcome Measures
Name Time Method