HealthyPhase 1NCT00836576
Benazepril HCl 40 mg Tablets, Fasting
A Phase 1 study testing Benazepril HCl 40 mg Tablets and Lotensin® 40 mg Tablets in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the oral bioavailability of a test benazepril HCl formulation (TEVA Pharmaceutical Industries Ltd.) to an equivalent oral dose of the commercially available benazepril HCl (Lotensin®, Novartis Pharmaceuticals Corporation) in a… 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?
- Benazepril HCl 40 mg Tablets and Lotensin® 40 mg Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Mar 2001
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Sex: Male and Female; similar proportions of each preferred.
- Age: At least 18 years.
- Subjects must have a minimum weight of at least 110 pounds.
- Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:
- Laboratory Tests: Hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Na, K, Cl), fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LDH, alkaline phosphatase, and urinalysis. HIV, Hepatitis B, Hepatitis C, and drugs of abuse testing will be done for screening purposes only. Laboratory values which are greater than ± 20% of the normal range will not qualify unless specifically accepted (with comment) by the Principal Investigator. Results of HIC, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study. Additional drugs of abuse testing will be done at check-in for each period. Tests are to be negative as a requirement for dosing. Female subjects will have a urine pregnancy test done at screening and prior to each study period at check-in.
- Electrocardiogram: A 12-lead electrocardiogram will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.
- Subjects must read and sign the Consent Form.
Who cannot join
- Subjects no complying with the above inclusion criteria must be excluded from the study.
- In addition one of the conditions listed below will exclude a subject from the study:
- History of treatment for alcoholism, drug abuse, or substance abuse within the past 24 months.
- History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
- History of treatment for asthma within the past five (5) years.
- History of treatment for any gastrointestinal disorder within the past five (5) years.
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- History of neutropenia.
- History of hyperkalemia.
- History of angioedema.
- History of impaired renal function.
- History of persistent nonproductive cough.
- Females who are pregnant or lactating.
- History of hypersensitivity to benazepril HCl, or any angiotensin-converting enzyme (ACE) inhibitor.
- Conditions upon screening which might contraindicate or require that caution be used in the administration of benazepril HCl, including:
- Sitting systolic blood pressure below 90 mmHg, or diastolic pressure below 50 mmHg.
- Heart rate less than 50 beats per minute after a 5-minute rest in a seated position.
- Inability to read and/or sign the consent form.
- Treatment with any other investigational drug during the four (4) weeks prior to enrollment into the study.
- Subjects who have donated blood within four (4) weeks prior to entry into the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gateway Medical Research, Inc.
Saint Charles, Missouri, 63301
About this study
Official title: A Randomized, Two-way Crossover, Single-dose, Open-label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Benazepril HCl (40 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Lotensin®, Novartis Pharmaceuticals Corporation) in 40 Fasted, Healthy, Adult Subjects
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the oral bioavailability of a test benazepril HCl formulation (TEVA Pharmaceutical Industries Ltd.) to an equivalent oral dose of the commercially available benazepril HCl (Lotensin®, Novartis Pharmaceuticals Corporation) in a test population of 40 adults under fasting conditions.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- Benazepril HCl 40 mg Tablets, Lotensin® 40 mg Tablets
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benazepril HCl 40 mg TabletsDrug
1 x 40 mg, single-dose fasting
Lotensin® 40 mg TabletsDrug
1 x 40 mg, single-dose fasting
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Benazepril HCl 40 mg Tablets |
| 2 | Active comparator | Not described Receives: Drug: Lotensin® 40 mg Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax for Benazepril
Measured: Blood samples collected over 96 hours
Bioequivalence based on AUC0-inf for Benazepril
Measured: Blood samples collected over 96 hour period
Bioequivalence based on AUC0-t for Benazepril
Measured: Blood samples collected over 96 hour period
Secondary outcomes (3)
Cmax results for Benazeprilat
Measured: Blood samples collected over 96 hour period
AUC0-inf results for Benazeprilat
Measured: Blood samples collected over 96 hour period
AUC0-t results for Benazeprilat
Measured: Blood samples collected over 96 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2001
- Primary completionMar 2001
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Siler, M.D., Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836576
- Sponsor's protocol ID
- 01002
- Status last verified
- Aug 2024
- First submitted
- 3 Feb 2009
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two-way Crossover, Single-dose, Open-label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Benazepril HCl (40 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Lotensin®, Novartis Pharmaceuticals Corporation) in 40 Fasted, Healthy, Adult Subjects
- ClinicalTrials.gov ID
- NCT00836576
- Acronym / sponsor ID
- 01002
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Mar 2001 (actual)
- Study completion
- Mar 2001 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
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 randomized, single-dose, two-way crossover evaluation is to compare the oral bioavailability of a test benazepril HCl formulation (TEVA Pharmaceutical Industries Ltd.) to an equivalent oral dose of the commercially available benazepril HCl (Lotensin®, Novartis Pharmaceuticals Corporation) in a test population of 40 adults 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 |
|---|---|---|
| 1 | Experimental | Drug: Benazepril HCl 40 mg Tablets |
| 2 | Active comparator | Drug: Lotensin® 40 mg Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Sex: Male and Female; similar proportions of each preferred.
- Age: At least 18 years.
- Subjects must have a minimum weight of at least 110 pounds.
- Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:
- Subjects must read and sign the Consent Form.
Key exclusion criteria (19 listed)
- Subjects no complying with the above inclusion criteria must be excluded from the study.
- In addition one of the conditions listed below will exclude a subject from the study:
- Conditions upon screening which might contraindicate or require that caution be used in the administration of benazepril HCl, including:
- Inability to read and/or sign the consent form.
- Treatment with any other investigational drug during the four (4) weeks prior to enrollment into the study.
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 |
|---|---|---|
| Benazepril HCl 40 mg Tablets1 x 40 mg, single-dose fasting | Drug | 1 |
| Lotensin® 40 mg Tablets1 x 40 mg, single-dose fasting | Drug | 2 |
Primary outcome
Bioequivalence based on Cmax for Benazepril
Time frame: Blood samples collected over 96 hours
Bioequivalence based on AUC0-inf for Benazepril
Time frame: Blood samples collected over 96 hour period
Bioequivalence based on AUC0-t for Benazepril
Time frame: Blood samples collected over 96 hour period
3 secondary outcomes
Cmax results for Benazeprilat
Time frame: Blood samples collected over 96 hour period
AUC0-inf results for Benazeprilat
Time frame: Blood samples collected over 96 hour period
AUC0-t results for Benazeprilat
Time frame: Blood samples collected over 96 hour period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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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.
Thomas Siler, M.D. principal investigator
Cetero Research, San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Benazepril HCl 40 mg Tablets and Lotensin® 40 mg Tablets in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
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 7 inclusion and 19 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bioequivalence based on Cmax for Benazepril (time frame: Blood samples collected over 96 hours). The study lists 3 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 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.