Bioequivalence Study of Fosinopril 40mg Tablets Under Fed Conditions

October 20, 2008 updated by: Ranbaxy Laboratories Limited

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St.charles, Missouri, United States, 63301
        • Gateway Medical Research Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

Hematology:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ranbaxy Laboratories Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

October 1, 2002

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (Estimate)

October 21, 2008

Study Record Updates

Last Update Posted (Estimate)

October 21, 2008

Last Update Submitted That Met QC Criteria

October 20, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B025508

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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