Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00835367
First received: January 30, 2009
Last updated: July 6, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Amlodipine-benazepril 10 mg-20 mg capsules
Drug: Lotrel® 10 mg-20 mg capsule
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Amlodipine [ Time Frame: Blood samples collected over 168 hour period ] [ Designated as safety issue: No ]
  • AUC0-Inf - Amlodipine [ Time Frame: Blood samples collected over 168 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Amlodipine [ Time Frame: Blood samples collected over 168 hour period ] [ Designated as safety issue: No ]
  • Cmax - Benazepril [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]
  • AUC0-Inf - Benazepril [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Benazepril [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax - Benazeprilat [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]
  • AUC0-Inf - Benazeprilat [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Benazeprilat [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: March 2004
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amlodipine Benazepril
Amlodipine Benazepril 10mg-20mg Capsule (test) dosed in first period followed by Lotrel® 10mg-20mg Capsule (reference) dosed in second period
Drug: Amlodipine-benazepril 10 mg-20 mg capsules
1 x 10-20 mg
Active Comparator: Lotrel®
Lotrel® 10mg-20mg Capsule (reference) dosed in first period followed by Amlodipine Benazepril 10mg-20mg Capsule (test) dosed in second period
Drug: Lotrel® 10 mg-20 mg capsule
1 x 10-20 mg

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835367

Locations
Canada, Quebec
Anapharm Inc.
Montreal, Quebec, Canada, H2X 2H9
SFBC Anapharm
Sainte-Foy, Quebec, Canada, G1V 2K8
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Richard Larouche, M.D. Anapharm
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00835367     History of Changes
Other Study ID Numbers: 40013
Study First Received: January 30, 2009
Results First Received: May 6, 2009
Last Updated: July 6, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Amlodipine
Benazepril
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014