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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: International Bio service · Network
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-04-23
• Completion: 2024-04-26
• First posted: 2024-01-29
• Last updated: 2024-01-29