HealthyNCT00776334
Bioequivalence Study of Fosinopril 40mg Tablets Under Fasting Conditions
A study testing Fosinopril 40mg Tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
Trial 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 fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fosinopril 40mg Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Dec 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gateway Medical Research Inc.
Saint Charles, Missouri, 63301
About this study
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® (Bristol-Myers Squibb, Lot No. 1D47960), in Healthy Adult Subjects Under 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 fasting conditions.
Read the 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 fasting conditions
Eligible subjects underwent pre-study examinations that included a physical examination, 12-1cad 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.
Forty (40) subjects were enrolled in this study; 39 completed the study.
- Conditions
- Healthy
- Being tested
- Fosinopril 40mg Tablets
- Keywords
- bioequivalence Fosinopril Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosinopril 40mg TabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | fosinopril sodium 40 mg tablets of Ranbaxy Receives: Drug: Fosinopril 40mg Tablets |
| 2 | Active comparator | Monopril® 40mg tablets Receives: Drug: Fosinopril 40mg Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startOct 2002
- Primary completionNov 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776334
- Sponsor's protocol ID
- B025507
- Status last verified
- Oct 2008
- First submitted
- 17 Oct 2008
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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® (Bristol-Myers Squibb, Lot No. 1D47960), in Healthy Adult Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT00776334
- Acronym / sponsor ID
- B025507
- Conditions
- Healthy
- Keywords
- bioequivalence Fosinopril Tablets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Nov 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 fasting conditions.
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 fasting conditions
Eligible subjects underwent pre-study examinations that included a physical examination, 12-1cad 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.
Forty (40) subjects were enrolled in this study; 39 completed the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fosinopril 40mg Tabletsfosinopril sodium 40 mg tablets of Ranbaxy |
| 2 | Active comparator | Drug: Fosinopril 40mg TabletsMonopril® 40mg tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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,
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosinopril 40mg Tablets | Drug | 1, 2 |
Primary outcome
Bioequivalence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fosinopril 40mg Tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2008.