drugset / Trial / NCT02332174
Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects
Phase 1
Completed
40 enrolled
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RandomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2014-03
- Primary completion
- 2014-06
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rufinamide | Small molecule | 200 mg | Oral |
| Subject | Rufinamide | Small molecule | 400 mg | Oral |
| Subject | Rufinamide | Small molecule | 800 mg | Oral |
| Subject | Rufinamide | Small molecule | 1200 mg | Oral |