Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects
NCT02332174 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2015-01-06
Summary
The purpose of this study was to determine the pharmacokinetic (PK) and safety profile of single and multiple doses of rufinamide. The effects of food and sex on the PK properties of rufinamide in these Chinese volunteers were also evaluated.
Conditions
Interventions
- DRUG
-
rufinamide
comparison of different doses, sex and medication conditions
Sponsors & Collaborators
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
Weiyong Li, PhD · Tongji Medical College, Huazhong University of Science and Technology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2014-06-30
- Completion
- 2014-06-30
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