Dyspepsia
Conditions
Keywords
levosulpiride, pharmacokinetics, adverse effects, bioavailability
Brief 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.
Detailed description
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.
Interventions
DRUGLevosulpiride
different formulations of levosulpiride
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | two days | Peak concentration |
| Area under the curve-AUC | two days | Area under the curve - plasma concentration |
| Clearance-CL | two days | Clearance |
| Apparent volume of distribution-V | two days | The apparent volume of distribution |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety (adverse events) | one month | adverse events |
Outcome results
None listed