To Determine the Bioequivalence Study Under FastingPhase 1NCT00652665
Bioavailability Study of Leflunomide Tablets Under Fasting Conditions
A Phase 1 study testing Leflunomide and ARAVA in people with To Determine the Bioequivalence Study Under Fasting, run by Par Pharmaceutical, Inc..
Trial summary
To compare the single-dose Bioavailability of Kali and Aventis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Determine the Bioequivalence Study Under Fasting
- What is being tested?
- Leflunomide and ARAVA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Jul 2003
- Phase
- Phase 1
- 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
- All subjects selected for this study will be at least 18 years of age.
- Females must be physically unable to become pregnant.
- Males must be vasectomized.
- Each subject shall be given a general physical examination within 28 days of initiation of the study.
- Such examination includes, but is not limited to, blood pressure, general observations, and history.
- Each female subject will be given a serum pregnancy test as part of the pre- study screening process
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- At the end of study, the subject will have an exit evaluation consisting of interim history, global evaluation, clinical laboratory measurements
- Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements
- Clinical laboratory measurements will include hematology, clinical chemistry, urine analysis, HIV screen, hepatitis-B,C screen, drugs of abuse screen before dosing.
Who cannot join
- Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction,or recent 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 tahn 20% outside the normal range may be retested.If the clinical values are out side 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 should be excluded from the study.Subjects who have a history of allergic responses to cholestyramine should be excluded from the study.
- All subjects will have urine samples assayed for the presence of drugs and abuse as part of the clinical laboratory screening procedures and at check-in before dosing. 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 drug within thirty(30)days prior to the first dosing of the study will not be allowed to participate.
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- 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.
- All female subjects will be screened for pregnancy at check-in. Subjects with positive or inconclusive results will be withdrawn from the study.
- Male subjects who are physically able to father a child will not be allowed to participate. Male subjects must be vasectomized(at least 3 months) with medical verification.
- Subjects who have taken any product containing leflunomide within 180 days of dosing will not be allowed to participate in this study.
About this study
Official title: To Compare the Relative Bioavailability of Leflunomide 20mg Tablets (Kali) With That of ARAVA 20mg Tablets(Aventis) Under Fasting Conditions
To compare the single-dose Bioavailability of Kali and Aventis
Read the detailed description
To compare the relative Bioavailability of leflunomide 20mg tablets with that of ARAVA 20mg tablets in healthy, adult subjects under fasting conditions
- Being tested
- Leflunomide, ARAVA
- Keywords
- Bioequivalence, single-dose, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeflunomideDrug
Also called ARAVA
Tablets, 20mg, single-dose
ARAVADrug
Also called Leflunomide
Tablets, 20mg,single-dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects received kali product under fasting conditions Receives: Drug: Leflunomide |
| B | Active comparator | Subjects received Aventis product under fasting conditions Receives: Drug: ARAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startJun 2003
- Primary completionJul 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine the Bioequivalence Study Under FastingStudies 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Investigators
- So Ran Hong, Principal investigator, Novum Pharmaceutical Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652665
- Sponsor's protocol ID
- B033201
- Status last verified
- Mar 2008
- First submitted
- 1 Apr 2008
- Last updated
- 4 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Relative Bioavailability of Leflunomide 20mg Tablets (Kali) With That of ARAVA 20mg Tablets(Aventis) Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00652665
- Acronym / sponsor ID
- B033201
- Keywords
- Bioequivalence, single-dose, fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Study start
- Jun 2003
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 4 Apr 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.
To compare the single-dose Bioavailability of Kali and Aventis
Detailed description
To compare the relative Bioavailability of leflunomide 20mg tablets with that of ARAVA 20mg tablets in healthy, adult subjects under fasting conditions
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: LeflunomideSubjects received kali product under fasting conditions |
| B | Active comparator | Drug: ARAVASubjects received Aventis product under fasting conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All subjects selected for this study will be at least 18 years of age.
- Females must be physically unable to become pregnant.
- Males must be vasectomized.
- Each subject shall be given a general physical examination within 28 days of initiation of the study.
- Such examination includes, but is not limited to, blood pressure, general observations, and history.
Key exclusion criteria (10 listed)
- Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction,or recent 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 tahn 20% outside the normal range may be retested.If the clinical values are out side 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 should be excluded from the study.Subjects who have a history of allergic responses to cholestyramine should be excluded from the study.
- All subjects will have urine samples assayed for the presence of drugs and abuse as part of the clinical laboratory screening procedures and at check-in before dosing. 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 |
|---|---|---|
| LeflunomideAlso: ARAVATablets, 20mg, single-dose | Drug | A |
| ARAVAAlso: LeflunomideTablets, 20mg,single-dose | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 24 Hours
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 4 Apr 2008.
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.
So Ran Hong principal investigator
Novum Pharmaceutical Research Services
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leflunomide and ARAVA in people with To Determine the Bioequivalence Study Under Fasting, run by Par Pharmaceutical, Inc..
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 9 inclusion and 10 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 4 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate and Extend of Absorption (time frame: 24 Hours). 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 4 Apr 2008.