COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Bioequivalence Study of Fosinopril 40mg Tablets Under Fed Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00776672
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : October 21, 2008
Information provided by:
Ranbaxy Inc.

Brief Summary:
The objective of this study is to compare the relative bioavailability of fosinopril sodium 40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in healthy adult subjects under non-fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Fosinopril 40mg Tablets Not Applicable

Detailed Description:

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on Fosinopril formulations comparing fosinopril 40mg tablets of Ranbaxy Laboratories with Monopril®, in healthy, adult, human, subjects under non-fasting conditions

Eligible subjects underwent pre-study examinations that included a physical examination, 12-lead ECG, and laboratory tests - including hematology, blood chemistries, urinalysis, infectious diseases (Hepatitis B, Hepatitis C, HIV), and urine drUgs of abuse. Laboratory testing for female subjects also included a serum pregnancy test.

Twenty four (24) subjects were enrolled in this study; 23 completed the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: The Objective of This Study is to Compare the Relative Bioavailability of Fosinopril Sodium 40 mg Tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) With That of Monopril® in Healthy Adult Subjects Under Non-Fasting Conditions
Study Start Date : October 2002
Actual Primary Completion Date : October 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
fosinopril sodium 40 mg tablets of Ranbaxy
Drug: Fosinopril 40mg Tablets
Active Comparator: 2
Monopril® 40mg tablets
Drug: Fosinopril 40mg Tablets

Primary Outcome Measures :
  1. Bioequivalence

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Non-institutionalized subjects consisting of members of the community at large.

Characterization of Study Group

  • All subjects selected for this study will be at least 18 years of age.
  • Clinical laboratory measurements will include the following:


  • hemoglobin, hematocrit,
  • red blood cell count,
  • platelets, and white blood cell count (with differential).

Clinical Chemistry:

  • creatinine, BUN, glucose, SGOT/AST,
  • SGPT/ALT, bilimbin, and alkaline phosphatase.

Urine Analysis:

  • pH, specific gravity, protein, glucose,
  • ketones, bilimbin, occult blood, and cells.

HIV Screen:

  • (pre-study only) Hepatitis-B, C Screen:
  • (pre-study only) Drugs of Abuse Screen: pre-study and at check-in each study period

Exclusion Criteria:

  • Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma(during past 5 years),diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  • Subjects who have a history of allergic responses to the class of drug being tested (including any penicillin product) should be excluded from the study.
  • All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at check-in each study period. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
  • Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
  • Subjects who have taken any investigational drag within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
  • Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (eg condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives (except Lunelle monthly injection) anytime during the 6 months prior to study dosing, Lunelle monthly injection anytime during the 45-days prior to study dosing or used hormonal contraceptives within 14 days before dosing will not be allowed to participate.
  • All female subjects will be screened for pregnancy at check in in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00776672

Layout table for location information
United States, Missouri
Gateway Medical Research Inc.
St.charles, Missouri, United States, 63301
Sponsors and Collaborators
Ranbaxy Laboratories Limited
Additional Information:
Layout table for additonal information
Responsible Party: Dr. Tausif Monif, Ranbaxy research laboratories Identifier: NCT00776672    
Other Study ID Numbers: B025508
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008
Keywords provided by Ranbaxy Inc.:
Bioequivalence Fosinopril Tablets
Additional relevant MeSH terms:
Layout table for MeSH terms
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents