Benazepril HCl 40 mg Tablets, Fasting

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00836576
First received: February 3, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 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 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

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: February 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 fasting
Active Comparator: 2 Drug: Lotensin® 40 mg Tablets
1 x 40 mg, single-dose fasting

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:

  • 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.
  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: NCT00836576

Locations
United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Thomas Siler, M.D. Cetero Research, San Antonio
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00836576     History of Changes
Other Study ID Numbers: 01002
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
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014