- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00836537
Benazepril HCl 40 mg Tablets, Fed
A Relative Bioavailability Study of 40 mg Benazepril Hydrochloride Tablets Under Non-Fasting Conditions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
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
Description
Inclusion Criteria:
- Screening Demographics: All volunteers for selected for this study will be healthy men or women 19 years of age or older at the time of dosing. The weight range will not exceed ±20% for height and body frame as per Desirable Weights for Men - 1983 Metropolitan height and Weight Table or as per Desirable Weights for Women - 1983 Metropolitan Height and Weight Table. Subjects must have a minimum weight of at least 110 pounds.
- Screening procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
Screening will include general observations, physical examination, demographics, medical and medication history, a 12-lead electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
The screening clinical laboratory procedures will include:
- Hematology: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count;
- Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase;
- HIV antibody, hepatitis B surface antigen, and hepatitis C antibody screens;
- Urinalysis: by dipstick; full microscopic examination if dipstick positive; and
- Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.
- Serum Pregnancy Screen (female volunteers only)
If female and:
- of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, sponge, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- is postmenopausal for at least 1 year; or
- is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy
Exclusion Criteria:
- Volunteers with a recent history of drug or alcohol addiction or abuse in the past 24 months.
- Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined bt the medical investigator).
- Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- Volunteers demonstrating a positive hepatitis B surface antigen screen, hepatitis C antibody screen or a reactive HIV antibody screen.
- Volunteers demonstrating a positive drug abuse screen when screened for this study.
- Female volunteers demonstrating a positive pregnancy screen.
- Female volunteers who are currently breastfeeding.
- Volunteers with a history of allergic response(s) to benazepril hydrochloride or related drugs.
- Volunteers with a history of clinically significant allergies including drug allergies.
- Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the medical investigator).
- Volunteers who currently use tobacco products. Three months abstinence is required.
- Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.
- Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weks after completing the study.
- Volunteers who report receiving any investigational drug within 30 days prior to period I dosing.
- Volunteers who report taking any prescription medication in the 14 days prior to Period I dosing and no OTC medications within 7 days prior to Period I dosing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
1 x 40 mg, single-dose fed
|
Active Comparator: 2
|
1 x 40 mg, single-dose fed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence based on AUC0-inf for Benazepril
Time Frame: Blood samples collected over 96 hour period
|
Blood samples collected over 96 hour period
|
Bioequivalence based on Cmax for Benazepril
Time Frame: Blood samples collected over 96 hour period
|
Blood samples collected over 96 hour period
|
Bioequivalence based on AUC0-t
Time Frame: Blood samples collected over 96 hour period
|
Blood samples collected over 96 hour period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax results for Benazeprilat
Time Frame: Blood samples collected over 96 hour period
|
Blood samples collected over 96 hour period
|
AUC0-inf results for Benazeprilat
Time Frame: Blood samples collected over 96 hour period
|
Blood samples collected over 96 hour period
|
AUC0-t results for Benazeprilat
Time Frame: Blood samples collected over 96 hour period
|
Blood samples collected over 96 hour period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James D. Carlson, Pharm. D., PRACS Institute, Ltd.
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01-050
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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