A Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study (NCT01380431) | Clinical Trial Compass
CompletedPhase 1
A Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study
United States18 participantsStarted 1999-08
Plain-language summary
The purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R).
Who can participate
Age range18 Years – 50 Years
SexMALE
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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 …