Pharmacokinetic Study of Levosulpiride

Levosulpiride was administered to 42 healthy male and female (1:1) subjects as tablet (orally) and injection (intramuscularly and intravenously) formulations. Blood samples were collected at regular intervals after single and multiple drug administration. The concentration of levosulpiride in plasma was determined using a validated high performance liquid chromatography-tandem mass spectrometry method. Non-compartmental analysis was performed to estimate pharmacokinetic parameters. The analysis of variance was used to test for linearity and assess the effect of gender on the pharmacokinetic properties of the study drug. Adverse effects were monitored using investigators' questionnaires and subjects' spontaneous reports, vital sign measurements, hematology, clinical chemistry, and electrocardiogram.

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