Pharmacokinetic Study of Levosulpiride

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tolerability and Pharmacokinetic Comparison of Oral, Intramuscular and Intravenous Administration of Levosulpiride After Single and Multiple Doses in Fasting Healthy Chinese Volunteers

Conditions
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Dyspepsia

Intervention / Treatment
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* Drug: Levosulpiride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: part 1<br>12 subjects successively received a single dose of levosulpiride tablets 25, 50, or 100 mg via oral administration and 50-mg of levosulpiride tablets 3 times a day for 7 days. | Drug: Levosulpiride<br>* different formulations of levosulpiride<br>|
| Experimental: part 2<br>30 subjects were randomly assigned to 1 of 3 treatment groups (25, 50, or 75 mg) via i.m. administration, the 50-mg group subjects also received levosulpiride by i.v. route and repeated administration by i.m. route (twice a day for 3 days). | Drug: Levosulpiride<br>* different formulations of levosulpiride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Peak concentration | two days | 
| Area under the curve-AUC | Area under the curve - plasma concentration | two days | 
| Clearance-CL | Clearance | two days | 
| Apparent volume of distribution-V | The apparent volume of distribution | two days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | adverse events | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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levosulpiride, pharmacokinetics, adverse effects, bioavailability