Benazepril HCl 40 mg Tablets, Fasting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00836576
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : February 4, 2009
Information provided by:
Teva Pharmaceuticals USA

Brief 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 test population of 40 adults under fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Benazepril HCl 40 mg Tablets Drug: Lotensin® 40 mg Tablets Phase 1

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : February 2001
Actual Primary Completion Date : March 2001
Actual Study Completion Date : March 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Benazepril HCl 40 mg Tablets
1 x 40 mg, single-dose fasting
Active Comparator: 2 Drug: Lotensin® 40 mg Tablets
1 x 40 mg, single-dose fasting

Primary Outcome Measures :
  1. Bioequivalence based on Cmax and AUC [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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:

    1. 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.
    2. 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.

Exclusion Criteria:

  • 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:

    1. History of treatment for alcoholism, drug abuse, or substance abuse within the past 24 months.
    2. History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
    3. History of treatment for asthma within the past five (5) years.
    4. History of treatment for any gastrointestinal disorder within the past five (5) years.
    5. History of neutropenia.
    6. History of hyperkalemia.
    7. History of angioedema.
    8. History of impaired renal function.
    9. History of persistent nonproductive cough.
    10. Females who are pregnant or lactating.
    11. 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:

    1. Sitting systolic blood pressure below 90 mmHg, or diastolic pressure below 50 mmHg.
    2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00836576

United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Teva Pharmaceuticals USA
Principal Investigator: Thomas Siler, M.D. Cetero Research, San Antonio Identifier: NCT00836576     History of Changes
Other Study ID Numbers: 01002
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by Teva Pharmaceuticals USA:
Healthy Subjects

Additional relevant MeSH terms:
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents