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Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets and Reference Product Under Fasting Conditions - Trial NCT06228443

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.

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NCT06228443
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06228443
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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

Study Focus

Healthy Volunteer

Leflunomide 20 mg Film-coated Tablet

Interventional

drug

Sponsor & Location

International Bio service

Timeline & Enrollment

Phase 1

Apr 01, 2024

Apr 26, 2024

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 person
Routine general health check-up of armed forces
Persons encountering health services in other circumstances
Persons encountering health services in other circumstances
Person encountering health services in unspecified circumstances

Data Source

ClinicalTrials.gov

NCT06228443

Non-Device Trial