Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects

Seizures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332174
• Other study ID #: TJXH-Rufi
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2015
• Last updated: January 3, 2015
• Start date: March 2014
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Seizures

Intervention

Drug:
• rufinamide
comparison of different doses, sex and medication conditions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC	the area under the concentration-time curve	three days	Yes