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

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ClinicalTrials.gov Identifier: NCT00883506
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:
Sandoz

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 24 participants
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.
Study Start Date : May 2000
Actual Primary Completion Date : June 2000
Actual Study Completion Date : June 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Lisinopril
U.S. FDA Resources

Arm Intervention/treatment
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.



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


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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.

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

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 Posted: April 17, 2009    Key Record Dates
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