A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers

Multiple Sclerosis Clinical Trial

Official title: An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Profiles of 14 mg Teriflunomide Tablet in Healthy Chinese Subjects

Status Completed

Clinical Trial Summary

Primary Objective:

To assess the pharmacokinetic (PK) parameters of teriflunomide after a single oral dose of 14 mg administration in Chinese healthy subjects

Secondary Objective:

To assess the safety and tolerability after a single oral dose of 14 mg teriflunomide in Chinese healthy subjects

Clinical Trial Description

• Screening: 2 to 21 days before inclusion (Day -21 to Day -2)

• Institutionalization period: 6 days including 1 treatment day (Day -1 to Day 6, treatment on Day 1)

• Follow-up: 7-10 days (may be extended)

• End of study: Day 38 to Day 41 (may be extended)

• Total study duration: maximum 9 weeks ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Multiple Sclerosis

• NCT number: NCT02046629
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 1
• Start date: May 2014
• Completion date: July 2014