Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-06-30

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.

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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.

Conditions

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Seizures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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200-mg group

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.

Group Type EXPERIMENTAL