Comparative Bioavailability Study of Lisinopril Tablets, 10 mg

This study has been completed.
Sponsor:
Collaborator:
PharmaKinetics Laboratories, Inc.
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT01375244
First received: April 1, 2008
Last updated: June 16, 2011
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Lisinopril
Drug: Zestril
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Rate and extent of absorption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: June 1999
Study Completion Date: October 1999
Primary Completion Date: October 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Subjects received the Par formulated product.
Drug: Lisinopril
Tablets, 10 mg, single dose
Other Name: Zestril
Active Comparator: B
Subjects received the IPR (Zeneca Pharmaceuticals) formulated product.
Drug: Zestril
Tablets, 10 mg, single dose
Other Name: lisinopril

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01375244

Locations
United States, Maryland
PharmaKinetics Laboratories, Inc.
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Par Pharmaceutical, Inc.
PharmaKinetics Laboratories, Inc.
Investigators
Principal Investigator: Clifford L Ferguson, MD PharmaKinetics Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT01375244     History of Changes
Other Study ID Numbers: 11506
Study First Received: April 1, 2008
Last Updated: June 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Par Pharmaceutical, Inc.:
bioequivalence
lisinopril
fasting

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

ClinicalTrials.gov processed this record on July 31, 2014