Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg

NCT00649519 | Completed Phase 1

• 1 other identifier: AMBE-0308
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a single, oral 10 mg/20 mg (1 x 10mg/20mg) dose administered under fasting conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  within 30 days

Study Arms (2)

1

EXPERIMENTAL

Amlodipine and Benazepril HCl Capsules 10 mg/20 mg

Drug: Amlodipine and Benazepril HCl Capsules 10 mg/20 mg

2

ACTIVE COMPARATOR

Lotrel® Capsules 10 mg/20 mg

Drug: Lotrel® Capsules 10 mg/20 mg

Interventions

Amlodipine and Benazepril HCl Capsules 10 mg/20 mg DRUG

10/20mg, single dose fasting

1

Lotrel® Capsules 10 mg/20 mg DRUG

10/20mg, single dose fasting

2

Eligibility Criteria

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

You may qualify if:

• \. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female.
• Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, serum samples for β-HCG testing may be collected and sent for analysis within 48 hours prior to dosing for both study periods. An additional serum (beta-HCG) pregnancy test will be performed upon completion of the study.
• Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
• intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
• barrier methods containing or used in conjunction with a spermicidal agent, or
• surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.
• During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form.
• \. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
• \. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, including vital signs, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

You may not qualify if:

• \. Institutionalized subjects will not be used. 2. Social Habits:
• Use of any tobacco products.
• Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
• Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
• Any recent, significant change in dietary or exercise habits. 3. Medications:
• a. Use of any medication within the 14 days prior to the initial dose of study medication.
• b. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
• c. Use of hormonal contraceptives and hormonal replacement therapy within three months prior to the initial dose of study medication.
• \. Diseases:
• History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
• History of angioedema.
• History of drug and/or alcohol abuse.
• Acute illness at the time of either the pre-study medical evaluation or dosing.
• Positive HIV, Hepatitis B, or Hepatitis C test. 5. Abnormal and clinically significant laboratory test results:
• <!-- -->

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

Location

Related Links

• Mylan Pharmaceuticals Inc. - Clinical Trial Results
• Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
• Recalls, Market Withdrawals and Safety Alerts

MeSH Terms

Interventions

Amlodipine; benazepril

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dorian Williams, M.D.

  Kendle International Inc.

  PRINCIPAL INVESTIGATOR

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: March 30, 2008
• First Posted: April 1, 2008
• Study Start: May 1, 2004
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

US (1)