HealthyNCT00778713
Bioequivalence Study of Fosinopril Sodium / Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fed Conditions
A study testing Fosinopril sodium and hydrochlorothiazide 20-12.5 mg 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 and hydrochlorothiazide 20-12.5 mg tablets of Ranbaxy laboratories Limited with that of Monopril ® - HCT 20-12.5 mg tablets by Bristol Meyers Squibb following a single oral dose (1 x 20/12.5 mg tablet) in healthy adult subjects… 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 sodium and hydrochlorothiazide 20-12.5 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Apr 2003
- 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
- Subjects should be at least 18 years old
- Female subjects with negative serum pregnancy test
- Subject with no clinically significant abnormal lab values at the pre-entry evaluation
- Subjects with negative or non-reactive urine drug of abuse, hepatitis B, hepatitis C and HIV screening
- Subject has acceptable ECG
- Subject has no evidence of underlying disease at the pre-entry physical examination
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- Subject has agreed to undergo at least a 14 day washout period for prescription drugs prior to the first dosing of the study and throughout the periods of blood sample collection
- Subject has agreed to undergo at least a 7 day washout period for OTC products, herbal medications, etc. prior to the first dosing of the study medication and throughout the periods of blood sample collections
- Subject agrees to abstain from consuming alcohol for at least 48 hours prior to each dosing and throughout the periods when blood samples are being obtained
- Subject agrees to abstain from consuming grapefruit, grapefruit juice, or other foods containing grapefruit for at least 48 hours prior to each dosing and throughout the periods when blood samples are being obtained
- Subject has given a written consent to participate
Who cannot join
- Subject has a history of chronic alcohol consumption (during past 2 years) or drug addiction
- Subject has a history of serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma
- Subject has a history of allergic responses to the class of drug being tests
- Subject has donated any blood and/ or plasma within the last thirty (30) days prior to the first dosing of the study
- Subject has taken any investigational drug within thirty (30) days prior to the first dosing of the study
- Female subjects who are pregnant, breast feeding, or likely to be come pregnant during the study. 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 the last blood collection)
- Female 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 the study dosing, or used oral hormonal contraceptives within 14 days before dosing.
- Subject with the inability to read and/ or sign the consent form
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: A Bioequivalence Study of Test and Reference Fosinopril Sodium/ Hydrochlorothiazide 20/ 12.5 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets of Ranbaxy laboratories Limited with that of Monopril ® - HCT 20-12.5 mg tablets by Bristol Meyers Squibb following a single oral dose (1 x 20/12.5 mg tablet) in healthy adult subjects under non-fasting conditions.
Read the detailed description
This study was a single dose, randomized, two-period, two-sequence, crossover design study. It was used to evaluate the relative bioavailability of the Fosinopril sodium and hydrochlorothiazide tablet products when dose (1 x 20/ 12.5 mg) under non-fasting conditions. There was a washout of at least a week between the two study periods.
A total of thirty six (36) healthy adult volunteers were recruited in the study of which only thirty three (33) subjects i.e. 18 males and 15 females completed the clinical portion of the study.
- Conditions
- Healthy
- Being tested
- Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets
- Keywords
- Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets of Ranbaxy laboratories Limited Receives: Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets |
| 2 | Active comparator | Monopril ® - HCT 20-12.5 mg tablets by Bristol Meyers Squibb following a single oral dose (1 x 20/12.5 mg tablet) Receives: Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg 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 posted23 Oct 2008 (estimated)
- Study startMar 2003
- Primary completionMar 2003
- Study completionApr 2003
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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778713
- Sponsor's protocol ID
- B035502
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 23 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study of Test and Reference Fosinopril Sodium/ Hydrochlorothiazide 20/ 12.5 mg Tablets Under Non-Fasting Conditions
- ClinicalTrials.gov ID
- NCT00778713
- Acronym / sponsor ID
- B035502
- Conditions
- Healthy
- Keywords
- Bioequivalence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Mar 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 23 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 and hydrochlorothiazide 20-12.5 mg tablets of Ranbaxy laboratories Limited with that of Monopril ® - HCT 20-12.5 mg tablets by Bristol Meyers Squibb following a single oral dose (1 x 20/12.5 mg tablet) in healthy adult subjects under non-fasting conditions.
Detailed description
This study was a single dose, randomized, two-period, two-sequence, crossover design study. It was used to evaluate the relative bioavailability of the Fosinopril sodium and hydrochlorothiazide tablet products when dose (1 x 20/ 12.5 mg) under non-fasting conditions. There was a washout of at least a week between the two study periods.
A total of thirty six (36) healthy adult volunteers were recruited in the study of which only thirty three (33) subjects i.e. 18 males and 15 females completed the clinical portion of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tabletsFosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets of Ranbaxy laboratories Limited |
| 2 | Active comparator | Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tabletsMonopril ® - HCT 20-12.5 mg tablets by Bristol Meyers Squibb following a single oral dose (1 x 20/12.5 mg tablet) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects should be at least 18 years old
- Female subjects with negative serum pregnancy test
- Subject with no clinically significant abnormal lab values at the pre-entry evaluation
- Subjects with negative or non-reactive urine drug of abuse, hepatitis B, hepatitis C and HIV screening
- Subject has acceptable ECG
Key exclusion criteria (8 listed)
- Subject has a history of chronic alcohol consumption (during past 2 years) or drug addiction
- Subject has a history of serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma
- Subject has a history of allergic responses to the class of drug being tests
- Subject has donated any blood and/ or plasma within the last thirty (30) days prior to the first dosing of the study
- Subject has taken any investigational drug within 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 sodium and hydrochlorothiazide 20-12.5 mg 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 23 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 sodium and hydrochlorothiazide 20-12.5 mg 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 11 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 23 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 23 Oct 2008.