To Determine Bioequivalence Under Fed ConditionsPhase 1NCT00653003
Bioavailability Study of Leflunomide Tablets Under Fed Conditions
A Phase 1 study testing Leflunomide and ARAVA in people with To Determine Bioequivalence Under Fed Conditions, 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 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- To Determine Bioequivalence Under Fed Conditions
- 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
- 62 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Jan 2004
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will meet all of the following criteria within 30 days prior to first drug administration(except inclusion #8)
- Healthy, surgically sterile (hysterectomy, bilateral oophorectomy) or postmenopausal (for al least 1 year)female subjects, 18 to 65 years of age(inclusive)
- Indicate non-child bearing status by one of the following criteria:
- Indication of successful hysterectomy. No spontaneous menses for al least 1 year, must have luteinizing hormone (LH) and follicle stimulating hormone(FSH) levels within postmenopausal range.
- Indication of successful bilateral oophorectomy.
- Body weight within 20% of the appropriate weight for the subject's height and frame (as published in the 1983 Metropolitan Life Insurance Company Scale, Statistical Bureau)
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- Negative for:
- HIV Hepatitis B surface antigen and Hepatitis C antibody Urine tests for drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
- Serum HCG consistent with pregnancy.
- No significant disease or clinically significant findings in a physical examination.
- No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram(ECG)
- Subjects who have received leflunomide within 4 months must have an A77-1726(Metabolite) level below 0.01ug/ml and no subsequent administration of leflunomide since that test. Note: The 30 day screening limit does not apply to this inclusion criterion.
- Be informed of the nature of the study and given written consent prior to receiving any study procedures.
Who cannot join
- Subject fulfilling any of the following criteria will be excluded from the study.
- Known history or presence of any clinically significant medical condition.
- Known or suspected carcinoma.
- Known history or presence of:
- Hypersensitivity or idiosyncratic reaction to leflunomide and/or any other drug substances with similar activity.
- Alcoholism within the last 12 months.
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- Drug dependence and/ or substance abuse.
- On a special diet within 4 weeks prior to drug administration(e.g. liquid, protein, raw food diet).
- Participated in another clinical trail or received an investigational product 30 days prior to drug administration.
- Donated up to 250 ml of blood in the past 45 days OR donated from 250 ml to 500 ml in the past 45 days OR donated 501 ml or more of blood in the past 56 days (based on the Canadian Blood Services guideline for blood donation).
- Requirement of any medication (prescription and/ or over-the-counter) on a routine basis, with the exception of hormonal replacement therapy, nutritional supplements and/or occasional use of common analgesics.
- Difficulty fasting or consuming the standard meals.
About this study
Official title: To Compare the Relative Bioavailability of Leflunomide 20mg Tablets (Kali) With That of ARAVA 20mg Tablets(Aventis) Under Fed 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 female subjects under fed conditions
- Being tested
- Leflunomide, ARAVA
- Keywords
- Bioequivalence, Leflunomide, fed
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
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 formulated product under fed conditions Receives: Drug: Leflunomide |
| B | Active comparator | Subjects received Aventis formulated products under fed 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 startDec 2003
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine Bioequivalence Under Fed ConditionsStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Investigators
- Xueyu Chen, Principal investigator, Pharma Medica Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653003
- Sponsor's protocol ID
- 2004-704
- Status last verified
- Sep 2017
- First submitted
- 1 Apr 2008
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. 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 Fed Conditions
- ClinicalTrials.gov ID
- NCT00653003
- Acronym / sponsor ID
- 2004-704
- Keywords
- Bioequivalence, Leflunomide, fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Study start
- Dec 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (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 female subjects under fed conditions
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: LeflunomideSubjects received Kali formulated product under fed conditions |
| B | Active comparator | Drug: ARAVASubjects received Aventis formulated products under fed conditions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects will meet all of the following criteria within 30 days prior to first drug administration(except inclusion #8)
- Healthy, surgically sterile (hysterectomy, bilateral oophorectomy) or postmenopausal (for al least 1 year)female subjects, 18 to 65 years of age(inclusive)
- Indicate non-child bearing status by one of the following criteria:
- Indication of successful hysterectomy. No spontaneous menses for al least 1 year, must have luteinizing hormone (LH) and follicle stimulating hormone(FSH) levels within postmenopausal range.
- Indication of successful bilateral oophorectomy.
Key exclusion criteria (12 listed)
- Subject fulfilling any of the following criteria will be excluded from the study.
- Known history or presence of any clinically significant medical condition.
- Known or suspected carcinoma.
- Known history or presence of:
- Hypersensitivity or idiosyncratic reaction to leflunomide and/or any other drug substances with similar activity.
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 26 Sep 2017.
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.
Xueyu Chen principal investigator
Pharma Medica Research, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leflunomide and ARAVA in people with To Determine Bioequivalence Under Fed Conditions, 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 13 inclusion and 12 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 26 Sep 2017. 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 26 Sep 2017; AzTrials last refreshed its copy on 30 Oct 2026.