Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions

NCT00834977 | Completed Phase 1 Results

• 1 other identifier: 40012
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to compare the rate and extent of absorption of amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered as 1 x 10 mg capsule under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (6)

• Cmax - Amlodipine

  Bioequivalence based on Cmax - Maximum observed concentration

  Blood samples collected over 168 hour period

• AUC0-inf - Amlodipine

  Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)

  Blood samples collected over 168 hour period

• AUC0-t - Amlodipine

  Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)

  Blood samples collected over 168 hour period

• Cmax - Benazepril

  Bioequvialence based on Cmax - Maximum observed concentration

  Blood samples collected over 36 hour period

• AUC0-inf - Benazepril

  Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)

  Blood samples collected over 36 hour period

• AUC0-t - Benazepril

  Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)

  Blood samples collected over 36 hour period

Secondary Outcomes (3)

• Cmax - Benazeprilat

  Blood samples collected over 36 hour period

• AUC0-inf - Benazeprilat

  Blood samples collected over 36 hour period

• AUC0-t - Benazaprilat

  Blood samples collected over 36 hour period

Study Arms (2)

Amlodipine Benazepril

EXPERIMENTAL

Amlodipine Benazepril 10mg-20mg Capsule (test) dosed in first period followed by Lotrel® 10mg-20mg Capsule (reference) dosed in second period

Drug: Amlodipine-benazepril 10 mg-20 mg capsules

Lotrel®

ACTIVE COMPARATOR

Lotrel® 10mg-20mg Capsule (reference) dosed in first period followed by Amlodipine Benazepril 10mg-20mg Capsules (test) dosed in second period

Drug: Lotrel® 10 mg-20 mg capsule

Interventions

Amlodipine-benazepril 10 mg-20 mg capsules DRUG

1 x 10-20 mg

Amlodipine Benazepril

Lotrel® 10 mg-20 mg capsule DRUG

1 x 10-20 mg

Lotrel®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male of non-child-bearing potential female, non-smoker, 18 years of age and older.
• Non-child-bearing potential female subjects is defined as follows:
• Post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy woth bilateral oophorectomy at least 6 months prior to drug administration.
• Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration.
• Capable of consent

You may not qualify if:

• Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
• Clinically significant surgery within 4 weeks prior to the administration of the study medication
• Any clinically significant abnormality found during medical screening.
• Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
• Abnormal laboratory tests judges clinically significant.
• Positive testing for hepatitis B, hepatitis C, or HIV at screening.
• EGC abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 ot over 140 nnHg, diastolic blood pressure lower than 60 or over 90 mmHg, or heart rate less that 60 or over 100 bpm) at screening.
• BMI ≥ 30.0
• History of significant alcohol abuse within six months prior to the screening visit or any indication of the regular use of more than fourteen units of alcohol per week ( 1 Unit= 150 mL of wine, 360 mL of beer, or 45 mL ot 40% alcohol) or positive alcohol breath test at screening.
• History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs( such as cocaine, phencyclidine \[PCP\] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
• History of allergic reactions to heparin,amlodipine,benazepril, or other ACE inhibitors, or other related drugs.
• Use of any drugs known to induce hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressant (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
• Use of and investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
• Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver of kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
• Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (2)

Anapharm Inc.

Montreal, Quebec, H3X H29, Canada

Location

SFBC Anapharm

Sainte-Foy, Quebec, G1V 2K8, Canada

Location

MeSH Terms

Interventions

benazepril

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: TEVA Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Richard Larouche, M.D.

  Anapharm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 3, 2009
• Study Start: April 1, 2004
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: September 19, 2024
• Results First Posted: August 18, 2009

Record last verified: 2024-08

Locations

CA (2)