Overview

A Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study

Status:
Completed
Trial end date:
1999-10-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R).
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Par Pharmaceutical, Inc.
Collaborator:
PharmaKinetics Laboratories Inc.
Treatments:
Lisinopril
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.