Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects

January 3, 2015 updated by: Weiyong Li, Wuhan Union Hospital, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Investigators

  • Principal Investigator: Weiyong Li, PhD, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 3, 2015

First Submitted That Met QC Criteria

January 3, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 3, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJXH-Rufi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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