Pharmacokinetic Study of Levosulpiride

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study was to characterise the pharmacokinetic properties and assess the safety of different formulations of levosulpiride in healthy Chinese volunteers.

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

Details

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

Criteria

Inclusion Criteria:

• body mass index between19 and 24 kg/m2

• negative for HIV and hepatitis B

• had no clinical important 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