Healthy VolunteerPhase 1NCT06228443
Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets and Reference Product Under Fasting Conditions
A Phase 1 study testing Leflunomide 20 mg Film-coated Tablet and ARAVA® 20 mg Film-coated Tablet in people with Healthy Volunteer, run by International Bio service.
Trial summary
This Study Aims to Assess the Relative Bioavailability, Including the Rate and Extent of Absorption, of 20 mg Leflunomide Tablets Compared to ARAVA® 20 mg Tablets. The Evaluation Will be Conducted Following a Single Oral Dose (1 x 20 mg Tablet) in Healthy Thai Male Volunteers Under Fasting Conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Leflunomide 20 mg Film-coated Tablet and ARAVA® 20 mg Film-coated Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 26 Apr 2024
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Thai male subjects between the ages of 18 to 55 years
- Body mass index between 18.5 to 30.0 kg/m2.
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
- Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study
- Male subjects who are not wishing to be a father of a child during the study or who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in until 30 days after investigational product administration.
- Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study
Who cannot join
- History of allergic reaction or hypersensitivity to leflunomide (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme), teriflunomide or any of the excipients in the tablet
- History of allergic reaction or hypersensitivity to cholestyramine
- History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper-/hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma, COPD), cardiovascular (e.g. hyper-/hypotension), psychiatric, neurologic (e.g. convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
- Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
- History about administration of COVID-19 vaccine within 30 days prior to check-in
- History or evidence of easy bruising or bleeding, recurrent infections, fever, paleness or unusual tiredness
Show all 37Show fewer
- History or evidence of impairment of liver function
- History or evidence of moderate to severe renal insuffici
- History or evidence of severe hypoproteinaemia or nephrotic syndrome
- Investigation with blood sample shows albumin level less than 3.5 g/dl or more than 5.2 g/dl at screening
- Investigation with blood sample shows total protein level less than 6.6 g/dl or more than 8.7 g/dl at screening
- History or evidence of severe immunodeficiency states
- History or evidence of significantly impaired bone marrow function, significant anaemia, leucopenia or thrombocytopenia
- Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day and check-in day. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 mins each. The last measurement value should be used to determine the subject's eligibility
- History or evidence of colitis
- History or evidence of peripheral neuropathy
- History or evidence of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption
- History of problems with swallowing tablet or capsule
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
- History of dehydration from diarrhea, vomiting, excess sweating or any other reason within 24 hours prior to check-in or prior to dosing
- History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
- 23.12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject's eligibility.
- 24.Investigation with blood sample shows positive test for HBsAg
- 25.Abnormal liver function, ≥1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
- 26.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in and continued for entire duration of the study
- 27.History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy, etc.)
- 28.History or eviden ce of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in and continued for entire duration of the study or alcohol breath test shows positive result.In case of alcohol breath test result represents the alcohol concentration range of 1 - 10 mg% BAC and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not more than 10 minutes. The result of the last time should be used for subject's eligibility which must be 0 mg%BAC.
- 29.History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 48 hours prior to check-in and continued for entire duration of the study
- 30.Consume or drink juice of grapefruit or orange or pomelo or its supplement/containing products and cannot abstain for at least 7 days prior to check-in and continued for entire duration of the study
- 31.Use of prescription or nonprescription drugs (e.g. paracetamol, erythromycin, ketoconazole, cimetidine, DMARDs (e.g. methotrexate), coumarin anticoagulants (e.g. warfarin), indomethacin, ketoprofen, furosemide, ciprofloxacin, cefaclor, zidovudine, benzylpenicillin, repaglinide, pioglitazone, rosiglitazone, paclitaxel, rosuvastatin, etc.), herbal medications or supplements (e.g. St. John's wort), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to check-in and continued for entire duration of the study
- 32.Participated in other clinical trials within 90 days prior to check-in (except for the subjects who drop out or withdrawn from the previous study prior to dosing) or still participates in the clinical trial or participates in other clinical trials during enrollment in this study
- 33.Blood donation or blood loss ≥ 1 unit (1 unit is equal to 350-450 mL of blood) within 90 days prior to check-in or during enrollment
- 34.Subjects with poor venous access or intolerant to venipuncture
- 35.Unwilling or unable to comply with schedule visit, treatment plan and other study procedures until end of study
- 36.Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide written informed consent or cooperate with clinical team
- 37.Subjects who are employees of International Bio Service Co. Ltd. or Sponsor.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single Dose, Randomized, Open-label, One-period Parallel Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets and Reference Product (Arava®) in Healthy Thai Male Volunteers Under Fasting Conditions
This Study Aims to Assess the Relative Bioavailability, Including the Rate and Extent of Absorption, of 20 mg Leflunomide Tablets Compared to ARAVA® 20 mg Tablets. The Evaluation Will be Conducted Following a Single Oral Dose (1 x 20 mg Tablet) in Healthy Thai Male Volunteers Under Fasting Conditions.
Read the detailed description
To compare the Bioavailability of leflunomide 20 mg tablets with that of ARAVA® 20mg tablets in healthy Thai Male Volunteers under fasting conditions
- Conditions
- Healthy Volunteer
- Being tested
- Leflunomide 20 mg Film-coated Tablet, ARAVA® 20 mg Film-coated Tablet
- Keywords
- Leflunomide, Bioequivalence Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leflunomide 20 mg Film-coated TabletDrug
Leflunomide 20 mg Film-coated Tablet (Test Drug)
ARAVA® 20 mg Film-coated TabletDrug
Also called Leflunomide 20 mg Film-coated Tablet
ARAVA® 20 mg Tablets (Reference Drug)
| Study group | Role | What they receive |
|---|---|---|
| Leflunomide 20 mg Tablets (Test Drug) | Experimental | Leflunomide 20 mg Tablets ,1 x 20 mg, single dose fasting. Receives: Drug: Leflunomide 20 mg Film-coated Tablet |
| ARAVA® 20 mg Tablets (Reference Drug) | Active comparator | ARAVA™ 20 mg Tablets,1 x 20 mg, single dose fasting. Receives: Drug: ARAVA® 20 mg Film-coated Tablet |
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
Measured: Blood samples collected over 72 hour period
AUC0-72
Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose
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 posted29 Jan 2024
- Study start1 Apr 2024 (estimated)
- Primary completion23 Apr 2024 (estimated)
- Study completion26 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Bio service
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Uthai Suvanakoot, Principal investigator, International Bio service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228443
- Sponsor's protocol ID
- BE23-031
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomized, Open-label, One-period Parallel Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets and Reference Product (Arava®) in Healthy Thai Male Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06228443
- Acronym / sponsor ID
- BE23-031
- Conditions
- Healthy Volunteer
- Keywords
- Leflunomide, Bioequivalence Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- International Bio serviceResearch network
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 23 Apr 2024 (estimated)
- Study completion
- 26 Apr 2024 (estimated)
- First posted
- 29 Jan 2024 (actual)
- 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.
This Study Aims to Assess the Relative Bioavailability, Including the Rate and Extent of Absorption, of 20 mg Leflunomide Tablets Compared to ARAVA® 20 mg Tablets. The Evaluation Will be Conducted Following a Single Oral Dose (1 x 20 mg Tablet) in Healthy Thai Male Volunteers Under Fasting Conditions.
Detailed description
To compare the Bioavailability of leflunomide 20 mg tablets with that of ARAVA® 20mg tablets in healthy Thai Male Volunteers under fasting conditions
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leflunomide 20 mg Tablets (Test Drug) | Experimental | Drug: Leflunomide 20 mg Film-coated TabletLeflunomide 20 mg Tablets ,1 x 20 mg, single dose fasting. |
| ARAVA® 20 mg Tablets (Reference Drug) | Active comparator | Drug: ARAVA® 20 mg Film-coated TabletARAVA™ 20 mg Tablets,1 x 20 mg, single dose fasting. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy Thai male subjects between the ages of 18 to 55 years
- Body mass index between 18.5 to 30.0 kg/m2.
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
- Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study
- Male subjects who are not wishing to be a father of a child during the study or who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in until 30 days after investigational product administration.
Key exclusion criteria (37 listed)
- History of allergic reaction or hypersensitivity to leflunomide (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme), teriflunomide or any of the excipients in the tablet
- History of allergic reaction or hypersensitivity to cholestyramine
- History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper-/hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma, COPD), cardiovascular (e.g. hyper-/hypotension), psychiatric, neurologic (e.g. convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
- Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
- History about administration of COVID-19 vaccine within 30 days prior to check-in
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 Film-coated TabletLeflunomide 20 mg Film-coated Tablet (Test Drug) | Drug | Leflunomide 20 mg Tablets (Test Drug) |
| ARAVA® 20 mg Film-coated TabletAlso: Leflunomide 20 mg Film-coated TabletARAVA® 20 mg Tablets (Reference Drug) | Drug | ARAVA® 20 mg Tablets (Reference Drug) |
Primary outcome
Cmax
Time frame: Blood samples collected over 72 hour period
Maximum Observed Concentration - Metabolite A77 1726 in Plasma
AUC0-72
Time frame: Blood samples collected over 72 hour period
Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Uthai Suvanakoot principal investigator
International Bio service
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leflunomide 20 mg Film-coated Tablet and ARAVA® 20 mg Film-coated Tablet in people with Healthy Volunteer, run by International Bio service.
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 6 inclusion and 37 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: status not confirmed, as of the sponsor's last update on 29 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nannapat Wannaphruek (024415211, nannapat.wan@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (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 29 Jan 2024.