Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Mylan Pharmaceuticals |
---|---|
Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00649597 |
The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg Drug: Lotensin HCT® Tablets 20 mg/25 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 Benazepril HCl and Hydrochlorothiazide Tablets (20 mg/25 mg; Mylan) to Lotensin HCT® Tablets (20 mg/25 mg; Novartis) in Healthy Volunteers |
Enrollment: | 56 |
Study Start Date: | November 2002 |
Study Completion Date: | December 2002 |
Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg
|
Drug: Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg
20/25mg, single dose fasting
|
2: Active Comparator
Lotensin HCT® Tablets 20 mg/25 mg
|
Drug: Lotensin HCT® Tablets 20 mg/25 mg
20/25mg, single dose fasting
|
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. 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, laboratory evaluation, 12-lead ECG, Hepatitis B, Hepatitis C and HIV testing, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, 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:
Use of any medication known to alter hepatic enzyme activity within 36 days prior to the initial dose of study medication, excluding hormonal contraceptives or hormonal replacement therapy initiated at least 3 months prior to study medication dosing.
4. Diseases:
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 HCl or hydrochlorothiazide 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.
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | James d Carlson, Pharm. D. | PRACS Institute Ltd. |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | BEHZ-0210 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00649597 |
Health Authority: | United States: Institutional Review Board |
Benazepril Healthy Hydrochlorothiazide |
Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Protease Inhibitors Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors |