Comparative Bioavailability Study of Lisinopril Tablets, 10 mg

June 16, 2011 updated by: Par Pharmaceutical, Inc.

Randomized, Open-label, Two-treatment Crossover, of a 10 mg Single Oral Dose, Study to Compare the Lisinopril Plasma Levels Produced After Administration of the Test Formulation With Those Produced After Administration of a Marketed Reference Product, Zestril(R), Under Fasting Conditions.

The purpose of this study is to compare the bioavailability of Par Lisinopril 10 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To compare the bioavailability of Par and IPR (Zestril(R)), Lisinopril 10 mg Tablets under fasting conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • PharmaKinetics Laboratories, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males, healthy, 18-50 years of age,
  • No more than plus or minus 15% from ideal weight for subject's height as defined by Metropolitan Life Insurance Company Statistical Bulletin 1983,
  • Without a history of asthma, angioedema, hypertension, psychiatric illness, organ-system (cardiovascular, neurological, hematopoietic, renal, pulmonary, endocrine, or gastrointestinal,) disorders, ongoing infectious diseases, alcohol or drug abuse as determined by a medical history and/or physical examination within 30 days prior to the start of the study. Deviations may be acceptable if deemed not clinically significant by the investigator.
  • Blood chemistry (including alkaline phosphatase, glucose, ALt, AST, LDH, BUN, GGT, creatinine, bilirubin, electrolytes), hematology (including hemoglobin, hematocrit, red blood cell count, white blood cell count, differential, platelet count), and urinalysis values within clinically acceptable limits upon evaluation by the investigator. The above tests will be performed within 30 days prior to the start of the study.
  • No prescription drugs within 14 days, or OTC preparations (with the exception of acetaminophen, vitamins, medicated lozenges, dietary supplements and topical medications) within 7 days of the first drug administration, each period. Deviations may be acceptable if evaluated by the investigator and determined not to be clinically significant.
  • No alcohol consumption for at least 48 hours prior to drug administration until after the last blood collection, each period.
  • No known allergy to lisinopril or other ACE (angiotensin converting enzyme) inhibitors, such as captopril and enalapril, or to atropine.
  • Acceptable electrocardiogram: sinus rhythm with no evidence of AV block or ischemic changes.
  • At screening and check-in for each period, subjects must have blood pressure and pulse rate within the following ranges: Systolic blood pressure (110-150 mmHg); Diastolic blood pressure (70-95 mmHg); Pulse (50-105 bpm). Minor deviations (1-3 mmHg) at check-in may be acceptable at the discretion of the physician investigator. For all except the first period check-in, if a subject's vital signs measurements fall outside the range specified above, the subject may, at the discretion of the physician investigator, be allowed to remain enrolled until 0-hour measurements are made. If the 0-hour protocol vital signs requirements are met, the investigator may allow dosing and the subject's continuation in the study. If 0-hour vital signs requirements are not met, the subject will not be dosed and must be withdrawn from the study. The blood pressure and pulse will be measured after the subject has been seated at least three minutes. Subjects with blood pressure and pulse measurements outside the ranges will have their vital signs measurements repeated according to Standard Operating Procedure.
  • No caffeine for at least 48 hours prior to dosing until after the last blood collection, each period.
  • Negative HIV 1, hepatitis B surface antigen and urine screen for drugs of abuse within 30 days prior to the start of the study.

Exclusion Criteria:

  • All Females, and males younger than 18 years of age or older than 50 years of age are not eligible to participate in this study.
  • A weight that is more than plus or minus 15% from ideal weight for subject's height as defined by Metropolitan Life Insurance Company Statistical Bulletin 1983.
  • A medical history of asthma, angioedema hypertension, psychiatric illness, organ-system (cardiovascular, neurological, hepatic, hematopoietic, renal, pulmonary, endocrine, or gastrointestinal) disorders, ongoing infectious diseases, alcohol or drug abuse within 30 days prior to start of the study.
  • Blood chemistry (including alkaline phosphatase, glucose, ALt, AST, LDH, BUN, GGT, creatinine, bilirubin, electrolytes), hematology (including hemoglobin, hematocrit, red blood cell count, white blood cell count, differential, platelet count), and urinalysis values not within clinically acceptable limits upon evaluation by the investigator. The above tests will be performed within 30 days prior to the start of the study.
  • Evidence of usage of prescription drugs within 14 days, or OTC preparations (with the exception of acetaminophen, vitamins, medicated lozenges, dietary supplements and topical medications) within 7 days of the first drug administration, each period.
  • Alcohol consumption within 48 hours prior to drug administration until.
  • Known allergy to lisinopril or other ACE (angiotensin converting enzyme) inhibitors, such as captopril and enalapril, or to atropine.
  • Unacceptable electrocardiogram: sinus rhythm with evidence of AV block or ischemic changes.
  • Blood pressure and pulse rate outside of the following ranges: Systolic blood pressure (110-150 mmHg); Diastolic blood pressure (70-95 mmHg); Pulse (50-105 bpm).
  • Evidence of caffeine use within the last 48 hours, prior to dosing, or through the study up to and after the last blood collection, each period.
  • A positive HIV 1, hepatitis B surface antigen and urine screen for drugs of abuse within 30 days prior to the start of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A
Subjects received the Par formulated product.
Drug: Lisinopril
Tablets, 10 mg, single dose
Other Names:
  • Zestril
Active Comparator: B
Subjects received the IPR (Zeneca Pharmaceuticals) formulated product.
Drug: Zestril
Tablets, 10 mg, single dose
Other Names:
  • lisinopril

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate and extent of absorption
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Par Pharmaceutical, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PharmaKinetics Laboratories Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 1999

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 1999

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 1999

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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