Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Rufinamide

Criteria

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