Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects
1 other identifier
interventional
40
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2014
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 3, 2015
CompletedFirst Posted
Study publicly available on registry
January 6, 2015
CompletedJanuary 6, 2015
January 1, 2015
3 months
January 3, 2015
January 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AUC
the area under the concentration-time curve
three days
Study Arms (4)
200-mg group
EXPERIMENTALTen healthy subjects were administered a single oral dose of 200 mg rufinamide tablets in fasted and fed state at day 1 and then received repeated oral doses of rufinamide (200 mg) once daily for 6 days.
400-mg group
EXPERIMENTALTen healthy subjects were administered a single oral dose of 400 mg rufinamide tablets in fasted state.
800-mg group
EXPERIMENTALTen healthy subjects were administered a single oral dose of 800 mg rufinamide tablets in fasted state.
1200-mg group
EXPERIMENTALTen healthy subjects were administered a single oral dose of 1200 mg rufinamide tablets in fasted state.
Interventions
comparison of different doses, sex and medication conditions
Eligibility Criteria
You may qualify if:
- body mass index between19 and 24 kg/m2
- negative for HIV and hepatitis B
- had no clinicallyimportant findings on health tests
- thorax radiography and ECG with no abnormalities
- normal blood pressure values
- heart rate
You may not qualify if:
- any drug treatment within 2 weeks before starting the study
- participation in another clinical study within the previous 3 months
- alcoholism and smoking
- pregnancy
- breast-feeding
- hypocalcemia
- blood donation or participation in other clinical trials within 3 months before enrollment in the study
- sitting blood pressure \<80/50 mm Hg or \>140/100 mm Hg
- A ventricular rate \<60 beats/min or \>100 beats/min at rest
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weiyong Li, PhD
Tongji Medical College, Huazhong University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Institute of Clinical Pharmacy
Study Record Dates
First Submitted
January 3, 2015
First Posted
January 6, 2015
Study Start
March 1, 2014
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
January 6, 2015
Record last verified: 2015-01