Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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This single- and multiple-dose, randomized, open-label study was conducted in healthy Chinese subjects. In the single-dose study, volunteers were randomly assigned to 4 dose groups and received a single dose of 200, 400, 800, 1200 mg rufinamide tablets under fasted condition. An additional food effect study was performed in the 200-mg dose group by assessing changes in PK parameters after high-fat diet. In the multiple-dose study, 10 subjects were administered 200-mg rufinamide formulation twice daily for 6 consecutive days. LC-MS/MS method was applied to determine plasma concentration of rufinamide. Tolerability was assessed based on investigator inquiries, spontaneous reports, and clinical evaluations such as standard laboratory tests, vital signs, physical examinations and 12-lead electrocardiography.

Official Title
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Pharmacokinetics and Tolerability of Rufinamide Following Single and Multiple Oral Doses and Effect of Food on Pharmacokinetics in Healthy Chinese Subjects

Conditions
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Seizures

Intervention / Treatment
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* Drug: rufinamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200-mg group<br>Ten 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. | Drug: rufinamide<br>* comparison of different doses, sex and medication conditions<br>* Other names: 106308-44-5;|
| Experimental: 400-mg group<br>Ten healthy subjects were administered a single oral dose of 400 mg rufinamide tablets in fasted state. | Drug: rufinamide<br>* comparison of different doses, sex and medication conditions<br>* Other names: 106308-44-5;|
| Experimental: 800-mg group<br>Ten healthy subjects were administered a single oral dose of 800 mg rufinamide tablets in fasted state. | Drug: rufinamide<br>* comparison of different doses, sex and medication conditions<br>* Other names: 106308-44-5;|
| Experimental: 1200-mg group<br>Ten healthy subjects were administered a single oral dose of 1200 mg rufinamide tablets in fasted state. | Drug: rufinamide<br>* comparison of different doses, sex and medication conditions<br>* Other names: 106308-44-5;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | the area under the concentration-time curve | three days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, food effect, sex effect, tolerability