Pharmacokinetic Study of Levosulpiride

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology42 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Dyspepsia

Interventions

LevosulpirideDRUG

different formulations of levosulpiride

Eligibility

Sex: ALLMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cmax

Peak concentration

Time frame: two days

Area under the curve-AUC

Area under the curve - plasma concentration

Time frame: two days

Clearance-CL

Clearance

Time frame: two days

Apparent volume of distribution-V

The apparent volume of distribution

Time frame: two days

Secondary Outcomes

Safety (adverse events)

adverse events

Time frame: one month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.