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

Healthy Volunteer Clinical Trial

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

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06228443
Study type Interventional
Source International Bio service
Contact Nannapat Wannaphruek
Phone 024415211
Email nannapat.wan@mahidol.ac.th
Status Not yet recruiting
Phase Phase 1
Start date April 1, 2024
Completion date April 26, 2024
View Details
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