Healthy
Conditions
Keywords
Bioequivalence, Healthy Subjects
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.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Interventions
1 x 40 mg, single-dose fasting
1 x 40 mg, single-dose fasting
Sponsors
Teva Pharmaceuticals USA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence based on Cmax for Benazepril | Blood samples collected over 96 hours |
| Bioequivalence based on AUC0-inf for Benazepril | Blood samples collected over 96 hour period |
| Bioequivalence based on AUC0-t for Benazepril | Blood samples collected over 96 hour period |
Secondary
| Measure | Time frame |
|---|---|
| Cmax results for Benazeprilat | Blood samples collected over 96 hour period |
| AUC0-inf results for Benazeprilat | Blood samples collected over 96 hour period |
| AUC0-t results for Benazeprilat | Blood samples collected over 96 hour period |
Countries
United States
Outcome results
None listed