Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02332174

Enrollment

Registered

2015-01-06

Start date

2014-03-31

Completion date

2014-06-30

Last updated

2015-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seizures

Keywords

pharmacokinetics, food effect, sex effect, tolerability

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.

Detailed 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.

Interventions

DRUGrufinamide

comparison of different doses, sex and medication conditions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
AUC	three days	the area under the concentration-time curve

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026