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To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablets Under Fasting Conditions

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.
ClinicalTrials.gov Identifier: NCT00883064
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablets Under Fasting Conditions.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA) Drug: Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, 2-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.
Study Start Date : March 2000
Primary Completion Date : April 2000
Study Completion Date : April 2000

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)
Drug: Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)
Active Comparator: 2
Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)
Drug: Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)


Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 23 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 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): NCT00883064


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: NCT00883064     History of Changes
Other Study ID Numbers: 00102
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