- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00835367
Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fed Conditions
July 6, 2009 updated by: Teva Pharmaceuticals USA
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 2H9
- Anapharm Inc.
-
Sainte-Foy, Quebec, Canada, G1V 2K8
- SFBC Anapharm
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Amlodipine Benazepril
Amlodipine Benazepril 10mg-20mg Capsule (test) dosed in first period followed by Lotrel® 10mg-20mg Capsule (reference) dosed in second period
|
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
|
1 x 10-20 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax - Amlodipine
Time Frame: Blood samples collected over 168 hour period
|
Bioequivalence based on Cmax - Maximum observed concentration
|
Blood samples collected over 168 hour period
|
AUC0-inf - Amlodipine
Time Frame: Blood samples collected over 168 hour period
|
Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
|
Blood samples collected over 168 hour period
|
AUC0-t - Amlodipine
Time Frame: Blood samples collected over 168 hour period
|
Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)
|
Blood samples collected over 168 hour period
|
AUC0-inf - Benazepril
Time Frame: Blood samples collected over 36 hour period
|
Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
|
Blood samples collected over 36 hour period
|
AUC0-t - Benazepril
Time Frame: Blood samples collected over 36 hour period
|
Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)
|
Blood samples collected over 36 hour period
|
Cmax - Benazepril
Time Frame: Blood samples collected over 36 hour period
|
Bioequivalence based on Cmax - Maximum observed concentration
|
Blood samples collected over 36 hour period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax - Benazeprilat
Time Frame: Blood samples collected over 36 hour period
|
Cmax - Maximum observed concentration
|
Blood samples collected over 36 hour period
|
AUC0-inf - Benazeprilat
Time Frame: Blood samples collected over 36 hour period
|
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
|
Blood samples collected over 36 hour period
|
AUC0-t - Benazeprilat
Time Frame: Blood samples collected over 36 hour period
|
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)
|
Blood samples collected over 36 hour period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Primary Completion (ACTUAL)
March 1, 2004
Study Completion (ACTUAL)
March 1, 2004
Study Registration Dates
First Submitted
January 30, 2009
First Submitted That Met QC Criteria
February 2, 2009
First Posted (ESTIMATE)
February 3, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 18, 2009
Last Update Submitted That Met QC Criteria
July 6, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nutrition Disorders
- Malnutrition
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin-Converting Enzyme Inhibitors
- Amlodipine
- Benazepril
Other Study ID Numbers
- 40013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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