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

To Determine Bioequivalence Under Fed Conditions Clinical Trial

Official title:

Randomized, Open-label, Three Treatment Crossover Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380431
• Other study ID #: 11508
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2008
• Last updated: June 22, 2011
• Start date: August 1999
• Est. completion date: October 1999

Study information

• Verified date: June 2011
• Source: Par Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R).

Description:

To compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R), 40 mg - Effect of Food Study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 1999
• Est. primary completion date: October 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• To Determine Bioequivalence Under Fed Conditions

Intervention

Drug:
• Lisinopril
Tablets, 40 mg, single oral dose
• lisinopril
Tablets, 40 mg, single, oral dose
• Lisinopril
50% of subjects received the Par formulated product.

Locations

Country	Name	City	State
United States	PharmaKinetics Laboratories, Inc.	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Par Pharmaceutical, Inc.	PharmaKinetics Laboratories Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence	Comparable food effect; The ratios of the test nd reference means and geometric means using the lease-squares means AUCo-t, AUCo-inf and Cmax should be within 80% - 125%.		No