Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fed Conditions
- Conditions
- Healthy
- Registration Number
- NCT00835367
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria:<br><br> - Male of non-child-bearing potential female, non-smoker, 18 years of age and older.<br><br> - Non-child-bearing potential female subjects is defined as follows:<br><br> - Post-menopausal state: absence of menses for 12 months prior to drug administration<br> or hysterectomy woth bilateral oophorectomy at least 6 months prior to drug<br> administration.<br><br> - Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least<br> 6 months prior to drug administration.<br><br> - Capable of consent<br><br>Exclusion Criteria:<br><br> - Clinically significant illnesses within 4 weeks prior to the administration of the<br> study 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 Sub-Investigator, would prevent the<br> subject from participating in the study.<br><br> - Abnormal laboratory tests judges clinically significant.<br><br> - Positive testing for hepatitis B, hepatitis C, or HIV at screening.<br><br> - EGC abnormalities (clinically significant) or vital sign abnormalities (systolic<br> blood pressure lower than 100 ot over 140 nnHg, diastolic blood pressure lower than<br> 60 or over 90 mmHg, or heart rate less that 60 or over 100 bpm) at screening.<br><br> - BMI = 30.0<br><br> - History of significant alcohol abuse within six months prior to the screening visit<br> or any indication of the regular use of more than fourteen units of alcohol per week<br> ( 1 Unit= 150 mL of wine, 360 mL of beer, or 45 mL ot 40% alcohol) or positive<br> alcohol breath test at screening.<br><br> - History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana)<br> within 3 months prior to the screening visit or hard drugs( such as cocaine,<br> phencyclidine [PCP] and crack) within 1 year prior to the screening visit or<br> positive urine drug screen at screening.<br><br> - History of allergic reactions to heparin, ramipril, or other ACE inhibitors, or<br> other related drugs.<br><br> - Use of any drugs known to induce hepatic drug metabolism (examples of inducers:<br> barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of<br> inhibitors: antidepressant (SSRI), cimetidine, diltiazem, macrolides, imidazoles,<br> neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to<br> administration of the study medication.<br><br> - Use of and investigational drug or participation in an investigational study within<br> 30 days prior to 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 of 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> - Use of prescription medication ( including hormone replacement therapy) within 14<br> days prior to administration of study medication or over-the-counter products<br> (including natural food supplements, vitamins, garlic as a supplement) within 7 days<br> prior to administration of study medication, except for topical products without<br> systemic absorption.<br><br> - Difficulty to swallow study medication. Subjects who have used tobacco in any form<br> within the 90 days preceding study drug administration<br><br> - Any food allergy, intolerance, restriction or special diet that, in the opinion of<br> the Medical Sub-Investigator, could contraindicate the subject's participation in<br> this study.<br><br> - A depot injection or an implant of any drug within 3 months prior to administration<br> of study medication.<br><br> - Donation of plasma (500 mL) within 30 days prior to drug administration. Donation or<br> loss of whole blood (excluding the volume of blood that will be drawn during the<br> screening procedures of this study) prior to administration of the study medication<br> as follows:<br><br> - 50 mL to 300 mL of whole blood within 30 days,<br><br> - 301 mL to 500 mL of whole blood within 45 days, or<br><br> - more than 500 mL of whole blood within 56 days prior to drug administration.<br><br> - Consumption of food or beverages containing grapefruit ( e.g. fresh, canned, or<br> frozen) within 7 days prior to administration of the study medication.<br><br> - Intolerance to venipunctures<br><br> - Unable to understand or unwilling to sign the Informed Consent Form.<br><br> - Clinically significant history of angioedema. Subjects with a clinically significant<br> history or active hypotension. Subjects with a significant history of active<br> neutropenia and/or agranulocytosis.<br><br> - Breast-feeding subject.<br><br> - Positive urine pregnancy test at screening.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax - Amlodipine;AUC0-inf - Amlodipine;AUC0-t - Amlodipine;Cmax - Benazepril;AUC0-inf - Benazepril;AUC0-t - Benazepril
- Secondary Outcome Measures
Name Time Method Cmax - Benazeprilat;AUC0-inf - Benazeprilat;AUC0-t - Benazeprilat