- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00649597
Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
North Dakota
-
Fargo, North Dakota, United States, 58104
- PRACS Institute, Ltd.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- 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.
Exclusion Criteria:
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:
- 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:
- 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:
- 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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg
|
20/25mg, single dose fasting
|
Active Comparator: 2
Lotensin HCT® Tablets 20 mg/25 mg
|
20/25mg, single dose fasting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence
Time Frame: within 30 days
|
within 30 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Angiotensin-Converting Enzyme Inhibitors
- Sodium Chloride Symporter Inhibitors
- Hydrochlorothiazide
- Benazepril
Other Study ID Numbers
- BEHZ-0210
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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