To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet Under Fasting and Fed - Full Text View

Sponsored by:	Sandoz Inc.
Information provided by:	Sandoz Inc.
ClinicalTrials.gov Identifier:	NCT00883506

Purpose

To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet under Fasting and Fed.

Condition	Intervention	Phase
Hypertension	Drug: Lisinopril 40 mg Tablet (Zestril) under fed conditions. Drug: Lisinopril 40 mg Tablet under fasting conditions. Drug: Lisinopril 40 mg Tablet under fed conditions.	Phase I

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Lisinopril

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	Randomized, 3-Way Crossover, Bioequivalence Study of Eon Labs Manufacturing Inc. (USA) and Zeneca (USA) (Zestril) 40 mg Lisinopril Tablet Administered as a 1 x 40 mg Tablet in Health Adult Males Under Fasting Conditions Under Fasting and Fed Conditions.

Further study details as provided by Sandoz Inc.:

Primary Outcome Measures:

Bioequivalence based on AUC and Cmax [ Time Frame: 50 days ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	May 2000
Study Completion Date:	June 2000
Primary Completion Date:	June 2000 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lisinopril 40 mg Tablet under fed conditions.	Drug: Lisinopril 40 mg Tablet under fed conditions.
2: Active Comparator Lisinopril 40 mg Tablet (Zestril)	Drug: Lisinopril 40 mg Tablet (Zestril) under fed conditions.
3: Experimental Lisinopril 40 mg Tablet under fasting conditions.	Drug: Lisinopril 40 mg Tablet under fasting conditions.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

Positive test results for HIV or hepatitis B or C.
Treatment for drug or alcohol dependence.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883506

Sponsors and Collaborators

Sandoz Inc.

Investigators

Principal Investigator:

Eric Masson, Pharm.D.

Anapharm

More Information

No publications provided

Responsible Party:	Sandoz Inc. ( Eric Mittleberg, Ph.D, VP of Product Development )
Study ID Numbers:	00104
Study First Received:	April 16, 2009
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00883506 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Lisinopril
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Agents

Antihypertensive Agents
Protease Inhibitors
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Lisinopril
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Protective Agents
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 06, 2009