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NCT06228443

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

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
International Bio service·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Volunteer
Drug/Device/Intervention
Leflunomide 20 mg Film-coated Tablet
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
International Bio service
Timeline & enrollment
Phase
Phase 1
Start date
Apr 01, 2024
End date
Apr 26, 2024
Enrollment
48 participants
Primary outcome

Cmax,AUC0-72

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.

ICD-10 classifications
Healthy person accompanying sick personRoutine general health check-up of armed forcesPersons encountering health services in other circumstancesPersons encountering health services in other circumstancesPerson encountering health services in unspecified circumstances
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06228443
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06228443 through Pure Global AI's free database. This Phase 1 trial is sponsored by International Bio service and is currently Not yet recruiting. The study focuses on Healthy Volunteer. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.