Benazepril HCl 40 mg Tablets, Fed

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00836537
First received: February 3, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

This study will compare the relative bioavailability (rate and extent of absorption) of 40 mg Benazepril Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 40 mg LOTENSIN® Tablets by Novartis Pharmaceuticals following a single oral dose (1 x 40 mg) in healthy adult volunteers under non-fasting conditions.


Condition Intervention Phase
Healthy
Drug: Benazepril HCl 40 mg Tablets
Drug: Lotensin® 40 mg Tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of 40 mg Benazepril Hydrochloride Tablets Under Non-Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2001
Study Completion Date: March 2001
Primary Completion Date: March 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Benazepril HCl 40 mg Tablets
1 x 40 mg, single-dose fed
Active Comparator: 2 Drug: Lotensin® 40 mg Tablets
1 x 40 mg, single-dose fed

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

    1. Hematology: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count;
    2. Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase;
    3. HIV antibody, hepatitis B surface antigen, and hepatitis C antibody screens;
    4. Urinalysis: by dipstick; full microscopic examination if dipstick positive; and
    5. Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.
    6. Serum Pregnancy Screen (female volunteers only)
  • If female and:

    1. 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.
    2. is postmenopausal for at least 1 year; or
    3. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836537

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: James D. Carlson, Pharm. D. PRACS Institute, Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00836537     History of Changes
Other Study ID Numbers: R01-050
Study First Received: February 3, 2009
Last Updated: February 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Benazepril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014