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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:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00883506
First received: April 16, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014