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

Phase 1

Not yet recruiting

• Conditions: Healthy Volunteer
• Interventions: Drug: Leflunomide 20 mg Film-coated Tablet; Drug: ARAVA® 20 mg Film-coated Tablet

• Registration Number: NCT06228443
• Lead Sponsor: International Bio service

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.

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

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Study Start: 2024-04-01
• Primary Completion: 2024-04-23
• Study Completion: 2024-04-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leflunomide 20 mg Tablets (Test Drug)	Leflunomide 20 mg Film-coated Tablet	Leflunomide 20 mg Tablets ,1 x 20 mg, single dose fasting.
ARAVA® 20 mg Tablets (Reference Drug)	ARAVA® 20 mg Film-coated Tablet	ARAVA™ 20 mg Tablets,1 x 20 mg, single dose fasting.

Primary Outcome Measures

Name	Time	Method
AUC0-72	Blood samples collected over 72 hour period	Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose
Cmax	Blood samples collected over 72 hour period	Maximum Observed Concentration - Metabolite A77 1726 in Plasma