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Bioequivalence Study of Fosinopril 40mg Tablets Under Fed Conditions

Information source: Ranbaxy Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Fosinopril 40mg Tablets (Drug)

Phase: N/A

Status: Completed

Sponsored by: Ranbaxy Laboratories Limited

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 MonoprilŪ in healthy adult subjects under non-fasting conditions.

Clinical Details

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 MonoprilŪ in Healthy Adult Subjects Under Non-Fasting Conditions

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

Primary outcome: Bioequivalence

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 MonoprilŪ, 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

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

Starting date: October 2002
Last updated: October 20, 2008

Page last updated: August 23, 2015

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