HealthyPhase 1NCT00834418
Leflunomide 20 mg Tablets Under Fasting Conditions
A Phase 1 study testing Leflunomide 20 mg Tablets and ARAVA™ 20 mg Tablets in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc. 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?
- Leflunomide 20 mg Tablets and ARAVA™ 20 mg Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Jul 2002
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Screening Demographics: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table.
- Screening procedures: Each subject will complete the screening process within 28 days prior to dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
- The screening clinical laboratory procedures will include:
- Hematology: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count;
- Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase;
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- HIV antibody and hepatitis B surface screens;
- Urinalysis: by dipstick; full microscopic examination if dipstick positive; and
- Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.
- Serum Pregnancy Screen (female subjects only)
- Follicle Stimulating Hormone [FSH] (females only to verify postmenopausal status)
- If male must be vasectomized (at least 3 months)
- If female and:
- is postmenopausal for at least 1 year; or
- is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Who cannot join
- Subjects with a recent history of drug or alcohol addiction or abuse.
- Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
- Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- Subjects demonstrating a positive hepatitis B surface antigen screen or reactive HIV antibody screen.
- Subjects demonstrating a positive drug abuse screen when screened for this study.
- Female subjects who are currently breastfeeding.
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- Female subjects demonstrating a positive pregnancy screen.
- Subjects with a history of allergic response(s) to leflunomide or related drugs.
- Subjects with a history of clinically significant allergies including drug allergies.
- Subjects with a clinically significant illness during the 4 weeks prior to dosing (as determined by the clinical investigators).
- Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.
- Subjects who report donating greater than 150 mL of blood within 30 days prior to dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
- Subjects who report receiving any investigational drug within 30 days prior to dosing.
- Subjects who report taking any prescription medication in the 14 days prior to dosing, with the exception of postmenopausal women on HRT may continue their HRT and topical products without systemic absorption.
- Subjects who report an intolerance of direct venipuncture.
- Subjects who report consuming an abnormal diet during the 28 days prior to dosing.
- Subjects who report taking any product containing leflunomide within 180 days of dosing.
- Subjects who report taking any herbal products within 7 days prior to dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Relative Bioavailability Study of 20 mg Leflunomide Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 20 mg tablet) in healthy adult subjects under fasting conditions.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- Leflunomide 20 mg Tablets, ARAVA™ 20 mg Tablets
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leflunomide 20 mg TabletsDrug
1 x 20 mg, single-dose fasting
ARAVA™ 20 mg TabletsDrug
1 x 20 mg, single-dose fasting
| Study group | Role | What they receive |
|---|---|---|
| Leflunomide | Experimental | Leflunomide 20 mg Tablet Receives: Drug: Leflunomide 20 mg Tablets |
| Arava™ | Active comparator | Arava™ 20 mg Tablet Receives: Drug: ARAVA™ 20 mg Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma
Bioequivalence based on Cmax
Measured: Blood samples collected over 72 hour period
AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose - Metabolite A77 1726
Bioequivalence based on AUC0-72
Measured: Blood samples collected over 72 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJun 2002
- Primary completionJul 2002
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James D. Carlson, Pharm.D., Principal investigator, PRACS Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834418
- Sponsor's protocol ID
- R02-561
- Status last verified
- Aug 2024
- First submitted
- 30 Jan 2009
- Last updated
- 20 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of 20 mg Leflunomide Tablets Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00834418
- Acronym / sponsor ID
- R02-561
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Jul 2002 (actual)
- Study completion
- Jul 2002 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 18 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 20 mg tablet) in healthy adult subjects under fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leflunomide | Experimental | Drug: Leflunomide 20 mg TabletsLeflunomide 20 mg Tablet |
| Arava™ | Active comparator | Drug: ARAVA™ 20 mg TabletsArava™ 20 mg Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Screening Demographics: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table.
- Screening procedures: Each subject will complete the screening process within 28 days prior to dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
- The screening clinical laboratory procedures will include:
- If male must be vasectomized (at least 3 months)
Key exclusion criteria (19 listed)
- Subjects with a recent history of drug or alcohol addiction or abuse.
- Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
- Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- Subjects demonstrating a positive hepatitis B surface antigen screen or reactive HIV antibody screen.
- Subjects demonstrating a positive drug abuse screen when screened for this 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 |
|---|---|---|
| Leflunomide 20 mg Tablets1 x 20 mg, single-dose fasting | Drug | Leflunomide |
| ARAVA™ 20 mg Tablets1 x 20 mg, single-dose fasting | Drug | Arava™ |
Primary outcome
Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma
Time frame: Blood samples collected over 72 hour period
Bioequivalence based on Cmax
AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose - Metabolite A77 1726
Time frame: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-72
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James D. Carlson, Pharm.D. principal investigator
PRACS Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leflunomide 20 mg Tablets and ARAVA™ 20 mg Tablets in people with Healthy, run by Teva Pharmaceuticals USA 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 15 inclusion and 19 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 20 Aug 2024. 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.
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?
Yes. Results are posted in the registry (first posted 18 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma (time frame: Blood samples collected over 72 hour period). The study lists 2 primary outcomes in all. 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 20 Aug 2024.