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

NCT06228443 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-01-29

No results posted yet for this study

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

Interventions

DRUG

Leflunomide 20 mg Film-coated Tablet

Leflunomide 20 mg Film-coated Tablet (Test Drug)

DRUG

ARAVA® 20 mg Film-coated Tablet

ARAVA® 20 mg Tablets (Reference Drug)

Sponsors & Collaborators

  • International Bio service

    lead NETWORK

Principal Investigators

  • Uthai Suvanakoot · International Bio service

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-04-23
Completion
2024-04-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06228443 on ClinicalTrials.gov