Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets and Reference Product Under Fasting Conditions

NCT06228443 | Unknown Phase 1

• 1 other identifier: BE23-031
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteer

Keywords

Leflunomide; Bioequivalence Study

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum Observed Concentration - Metabolite A77 1726 in Plasma

  Blood samples collected over 72 hour period

• AUC0-72

  Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose

  Blood samples collected over 72 hour period

Study Arms (2)

Leflunomide 20 mg Tablets (Test Drug)

EXPERIMENTAL

Leflunomide 20 mg Tablets ,1 x 20 mg, single dose fasting.

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.

Drug: ARAVA® 20 mg Film-coated Tablet

Interventions

Leflunomide 20 mg Film-coated Tablet DRUG

Leflunomide 20 mg Film-coated Tablet (Test Drug)

Leflunomide 20 mg Tablets (Test Drug)

ARAVA® 20 mg Film-coated Tablet DRUG

ARAVA® 20 mg Tablets (Reference Drug)

Also known as: Leflunomide 20 mg Film-coated Tablet

ARAVA® 20 mg Tablets (Reference Drug)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• International Bio service: lead

MeSH Terms

Interventions

Leflunomide

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Uthai Suvanakoot

  International Bio service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nannapat Wannaphruek

CONTACT

024415211; nannapat.wan@mahidol.ac.th

Thanaporn Wongyai

CONTACT

024415211; thanaporn.won@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 29, 2024
• Study Start: April 1, 2024
• Primary Completion: April 23, 2024
• Study Completion: April 26, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share