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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00883506
First Posted: April 17, 2009
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sandoz
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 50 days ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883506


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Eric Masson, Pharm.D. Anapharm
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00883506     History of Changes
Other Study ID Numbers: 00104
First Submitted: April 16, 2009
First Posted: April 17, 2009
Last Update Posted: March 29, 2017
Last Verified: March 2009

Additional relevant MeSH terms:
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs