Pharmacokinetic Study of Levosulpiride

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Dyspepsia

Clinical Trial Details

NCT number	NCT02481583
Study type	Interventional
Source	Wuhan Union Hospital, China
Contact
Status	Completed
Phase	Phase 1
Start date	March 2013
Completion date	May 2013

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