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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649519 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Amlodipine and Benazepril HCl Capsules 10 mg/20 mg Drug: Lotrel® Capsules 10 mg/20 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Amlodipine and Benazepril HCl Capsules (10 mg/20 mg; Mylan) to Lotrel® Capsules (10 mg/20 mg; Novartis) in Healthy Volunteers |
| Enrollment: | 54 |
| Study Start Date: | May 2004 |
| Study Completion Date: | May 2004 |
| Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Amlodipine and Benazepril HCl Capsules 10 mg/20 mg
|
Drug: Amlodipine and Benazepril HCl Capsules 10 mg/20 mg
10/20mg, single dose fasting
|
|
2: Active Comparator
Lotrel® Capsules 10 mg/20 mg
|
Drug: Lotrel® Capsules 10 mg/20 mg
10/20mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female.
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:
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.
3. 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).
4. 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.
Exclusion Criteria:
1. Institutionalized subjects will not be used. 2. Social Habits:
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.
4. Diseases:
d. Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
8. Allergy or hypersensitivity to benazepril or amlodipine or any other related products.
9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | AMBE-0308 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649519 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Amlodipine Protease Inhibitors Membrane Transport Modulators Therapeutic Uses Benazepril Angiotensin-Converting Enzyme Inhibitors |