Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects

Huazhong University of Science and Technology

Status and phase

Completed

Phase 1

Conditions

Seizures

Treatments

Drug: rufinamide

Study type

Interventional

Funder types

Other

Identifiers

NCT02332174

TJXH-Rufi

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 4 patient groups

200-mg group

Experimental group

Description:

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.

Treatment:

Drug: rufinamide

400-mg group

Experimental group

Description:

Ten healthy subjects were administered a single oral dose of 400 mg rufinamide tablets in fasted state.

Treatment:

Drug: rufinamide

800-mg group

Experimental group

Description:

Ten healthy subjects were administered a single oral dose of 800 mg rufinamide tablets in fasted state.