HealthyPhase 1NCT00834977
Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions
A Phase 1 study testing Amlodipine-benazepril 10 mg-20 mg capsules and Lotrel® 10 mg-20 mg capsule in people with Healthy, run by Teva Pharmaceuticals USA at 2 sites in Canada.
Trial summary
The objective of this study is to compare the rate and extent of absorption of amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered as 1 x 10 mg capsule under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Amlodipine-benazepril 10 mg-20 mg capsules and Lotrel® 10 mg-20 mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2004to May 2004
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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,amlodipine,benazepril, 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Anapharm Inc.
Montreal, Quebec, H3X H29
SFBC Anapharm
Sainte-Foy, Quebec, G1V 2K8
About this study
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 Fasting Conditions.
The objective of this study is to compare the rate and extent of absorption of amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered as 1 x 10 mg capsule under fasting conditions.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- Amlodipine-benazepril 10 mg-20 mg capsules, Lotrel® 10 mg-20 mg capsule
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine-benazepril 10 mg-20 mg capsulesDrug
1 x 10-20 mg
Lotrel® 10 mg-20 mg capsuleDrug
1 x 10-20 mg
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine Benazepril | Experimental | Amlodipine Benazepril 10mg-20mg Capsule (test) dosed in first period followed by Lotrel® 10mg-20mg Capsule (reference) dosed in second period Receives: Drug: Amlodipine-benazepril 10 mg-20 mg capsules |
| Lotrel® | Active comparator | Lotrel® 10mg-20mg Capsule (reference) dosed in first period followed by Amlodipine Benazepril 10mg-20mg Capsules (test) dosed in second period Receives: Drug: Lotrel® 10 mg-20 mg capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Amlodipine
Bioequivalence based on Cmax - Maximum observed concentration
Measured: Blood samples collected over 168 hour period
AUC0-inf - Amlodipine
Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: Blood samples collected over 168 hour period
AUC0-t - Amlodipine
Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)
Measured: Blood samples collected over 168 hour period
Cmax - Benazepril
Bioequvialence based on Cmax - Maximum observed concentration
Measured: Blood samples collected over 36 hour period
AUC0-inf - Benazepril
Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: Blood samples collected over 36 hour period
AUC0-t - Benazepril
Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)
Measured: Blood samples collected over 36 hour period
Secondary outcomes (3)
Cmax - Benazeprilat
Cmax - Maximum observed concentration
Measured: Blood samples collected over 36 hour period
AUC0-inf - Benazeprilat
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: Blood samples collected over 36 hour period
AUC0-t - Benazaprilat
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)
Measured: Blood samples collected over 36 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startApr 2004
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Larouche, M.D., Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834977
- Sponsor's protocol ID
- 40012
- Status last verified
- Aug 2024
- First submitted
- 30 Jan 2009
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Fasting Conditions.
- ClinicalTrials.gov ID
- NCT00834977
- Acronym / sponsor ID
- 40012
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 18 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the rate and extent of absorption of amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered as 1 x 10 mg capsule under fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amlodipine Benazepril | Experimental | Drug: Amlodipine-benazepril 10 mg-20 mg capsulesAmlodipine Benazepril 10mg-20mg Capsule (test) dosed in first period followed by Lotrel® 10mg-20mg Capsule (reference) dosed in second period |
| Lotrel® | Active comparator | Drug: Lotrel® 10 mg-20 mg capsuleLotrel® 10mg-20mg Capsule (reference) dosed in first period followed by Amlodipine Benazepril 10mg-20mg Capsules (test) dosed in second period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipine-benazepril 10 mg-20 mg capsules1 x 10-20 mg | Drug | Amlodipine Benazepril |
| Lotrel® 10 mg-20 mg capsule1 x 10-20 mg | Drug | Lotrel® |
Primary outcome
Cmax - Amlodipine
Time frame: Blood samples collected over 168 hour period
Bioequivalence based on Cmax - Maximum observed concentration
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)
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)
Cmax - Benazepril
Time frame: Blood samples collected over 36 hour period
Bioequvialence based on Cmax - Maximum observed concentration
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)
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)
3 secondary outcomes
Cmax - Benazeprilat
Time frame: Blood samples collected over 36 hour period
AUC0-inf - Benazeprilat
Time frame: Blood samples collected over 36 hour period
AUC0-t - Benazaprilat
Time frame: Blood samples collected over 36 hour period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Larouche, M.D. principal investigator
Anapharm
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amlodipine-benazepril 10 mg-20 mg capsules and Lotrel® 10 mg-20 mg capsule in people with Healthy, run by Teva Pharmaceuticals USA at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax - Amlodipine (time frame: Blood samples collected over 168 hour period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.