HealthyPhase 1NCT00649597
Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg
A Phase 1 study testing Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg and Lotensin HCT® Tablets 20 mg/25 mg in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.
Trial summary
The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration 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?
- Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg and Lotensin HCT® Tablets 20 mg/25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Dec 2002
- 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
- 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female.
- Women of childbearing potential must have negative serum -human chorionic gonadotropin (B-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, serum samples for β-HCG testing may be collected and sent for analysis within 48 hours prior to dosing for both study periods. An additional serum (beta-HCG) pregnancy test will be performed upon completion of the study.
- Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:
- oral contraceptives initiated at least 3 months prior to the start of the study and continued during the study, or
- intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
- barrier methods containing or used in conjunction with a spermicidal agent, or
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- postmenopausal or surgical sterility accompanied with a documented postmenopausal course of at least one year (tubal ligation, oophorectomy or hysterectomy).
- During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form.
- 3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- 4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, Hepatitis B, Hepatitis C and HIV testing, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
Who cannot join
- 1. Institutionalized subjects will not be used. 2. Social Habits:
- Use of any tobacco products.
- Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.
- Any recent, significant change in dietary or exercise habits.
- A positive test for any drug included in the urine drug screen. 3. Medications:
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- Use of any medication within the 14 days prior to the initial dose of study medication, excluding hormonal contraceptives or hormonal replacement therapy initiated at least 3 months prior to study medication dosing.
- Use of any medication known to alter hepatic enzyme activity within 36 days prior to the initial dose of study medication, excluding hormonal contraceptives or hormonal replacement therapy initiated at least 3 months prior to study medication dosing.
- 4. Diseases:
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- History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
- History of angioedema.
- History of drug and/or alcohol abuse.
- Acute illness at the time of either the pre-study medical evaluation or dosing.
- Positive test for HIV, Hepatitis B, or Hepatitis C. 5. Abnormal and clinically significant laboratory test results:
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- Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
- 7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- 8. Allergy or hypersensitivity to benazepril HCl or hydrochlorothiazide or any other related products.
- 9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
- 10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Dose Fasting In Vivo Bioequivalence Study of Benazepril HCl and Hydrochlorothiazide Tablets (20 mg/25 mg; Mylan) to Lotensin HCT® Tablets (20 mg/25 mg; Novartis) in Healthy Volunteers
The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting conditions.
- Conditions
- Healthy
- Being tested
- Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg, Lotensin HCT® Tablets 20 mg/25 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mgDrug
20/25mg, single dose fasting
Lotensin HCT® Tablets 20 mg/25 mgDrug
20/25mg, single dose fasting
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg Receives: Drug: Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg |
| 2 | Active comparator | Lotensin HCT® Tablets 20 mg/25 mg Receives: Drug: Lotensin HCT® Tablets 20 mg/25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startNov 2002
- Primary completionDec 2002
- Study completionDec 2002
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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James d Carlson, Pharm. D., Principal investigator, PRACS Institute Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649597
- Sponsor's protocol ID
- BEHZ-0210
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2008
- Last updated
- 24 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Fasting In Vivo Bioequivalence Study of Benazepril HCl and Hydrochlorothiazide Tablets (20 mg/25 mg; Mylan) to Lotensin HCT® Tablets (20 mg/25 mg; Novartis) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00649597
- Acronym / sponsor ID
- BEHZ-0210
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 1 Apr 2008 (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 study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting conditions.
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 and Hydrochlorothiazide Tablets 20 mg/25 mgBenazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg |
| 2 | Active comparator | Drug: Lotensin HCT® Tablets 20 mg/25 mgLotensin HCT® Tablets 20 mg/25 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female.
- 3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- 4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, Hepatitis B, Hepatitis C and HIV testing, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
Key exclusion criteria (23 listed)
- 1. Institutionalized subjects will not be used. 2. Social Habits:
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- 7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
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 and Hydrochlorothiazide Tablets 20 mg/25 mg20/25mg, single dose fasting | Drug | 1 |
| Lotensin HCT® Tablets 20 mg/25 mg20/25mg, single dose fasting | Drug | 2 |
Primary outcome
Bioequivalence
Time frame: within 30 days
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 24 Apr 2024.
- Mylan Pharmaceuticals Inc. - Clinical Trial ResultsLink provided by the sponsor.
- Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in useLink provided by the sponsor.
- Recalls, Market Withdrawals and Safety AlertsLink provided by the sponsor.
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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.
James d Carlson, Pharm. D. principal investigator
PRACS Institute Ltd.
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 and Hydrochlorothiazide Tablets 20 mg/25 mg and Lotensin HCT® Tablets 20 mg/25 mg in people with Healthy, run by Mylan Pharmaceuticals Inc 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 10 inclusion and 23 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 24 Apr 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 (time frame: within 30 days). 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 24 Apr 2024.