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
* 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:power Route of administration: oral
Investigational Site Number 156001
Shanghai, China
Pharmacokinetic parameters for teriflunomide determined from plasma concentration
Time frame: 5 weeks
safety assessments (adverse events, laboratory data, vital sign, and ECG parameters)
Time frame: 6 weeks
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