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Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects 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: Amlodipine-benazepril 10 mg-20 mg capsules (Drug); Lotrel® 10 mg-20 mg capsule (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Richard Larouche, M.D., Principal Investigator, Affiliation: Anapharm

Summary

The objective of this study is to compare the rate and extent of absorption if amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference),administered as 1 x 10 mg- 20 mg capsule under fed conditions.

Clinical Details

Official title: Randomized, 2-Way, Crossover, Bioequivalence Study of Amlodipine-Benazepril 10mg-20mg Capsules and Lotrel® Administered as 1 x 10 mg-20 mg Capsule in Healthy Subjects Under Fed Conditions.

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

Primary outcome:

Cmax - Amlodipine

AUC0-Inf - Amlodipine

AUC0-t - Amlodipine

Cmax - Benazepril

AUC0-Inf - Benazepril

AUC0-t - Benazepril

Secondary outcome:

Cmax - Benazeprilat

AUC0-Inf - Benazeprilat

AUC0-t - Benazeprilat

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:

- Male of non-child-bearing potential female, non-smoker, 18 years of age and older.

- Non-child-bearing potential female subjects is defined as follows:

- Post-menopausal state: absence of menses for 12 months prior to drug administration

or hysterectomy woth bilateral oophorectomy at least 6 months prior to drug administration.

- Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least

6 months prior to drug administration.

- Capable of consent

Exclusion Criteria:

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

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 Sub-Investigator, would prevent the

subject from participating in the study.

- Abnormal laboratory tests judges clinically significant.

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

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

blood pressure lower than 100 ot over 140 nnHg, diastolic blood pressure lower than 60 or over 90 mmHg, or heart rate less that 60 or over 100 bpm) at screening.

- BMI ≥ 30. 0

- History of significant alcohol abuse within six months prior to the screening visit

or any indication of the regular use of more than fourteen units of alcohol per week ( 1 Unit= 150 mL of wine, 360 mL of beer, or 45 mL ot 40% alcohol) or positive alcohol breath test at screening.

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

within 3 months prior to the screening visit or hard drugs( such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.

- History of allergic reactions to heparin, ramipril, or other ACE inhibitors, or other

related drugs.

- Use of any drugs known to induce hepatic drug metabolism (examples of inducers:

barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressant (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.

- Use of and investigational drug or participation in an investigational study within

30 days prior to 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 of 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.

- Use of prescription medication ( including hormone replacement therapy) within 14

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

- Difficulty to swallow study medication. Subjects who have used tobacco in any form

within the 90 days preceding study drug administration

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

the Medical Sub-Investigator, could contraindicate the subject's participation in this study.

- A depot injection or an implant of any drug within 3 months prior to administration

of study medication.

- Donation of plasma (500 mL) within 30 days prior to drug administration. Donation or

loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:

- 50 mL to 300 mL of whole blood within 30 days,

- 301 mL to 500 mL of whole blood within 45 days, or

- more than 500 mL of whole blood within 56 days prior to drug administration.

- Consumption of food or beverages containing grapefruit ( e. g. fresh, canned, or

frozen) within 7 days prior to administration of the study medication.

- Intolerance to venipunctures

- Unable to understand or unwilling to sign the Informed Consent Form.

- Clinically significant history of angioedema. Subjects with a clinically significant

history or active hypotension. Subjects with a significant history of active neutropenia and/or agranulocytosis.

- Breast-feeding subject.

- Positive urine pregnancy test at screening.

Locations and Contacts

Anapharm Inc., Montreal, Quebec H2X 2H9, Canada

SFBC Anapharm, Sainte-Foy, Quebec G1V 2K8, Canada

Additional Information

Starting date: March 2004
Last updated: July 6, 2009

Page last updated: August 23, 2015

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