NCT02481583

Pharmacokinetic Study of Levosulpiride

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
DRUG	Levosulpiride	different formulations of levosulpiride

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2015-06-25
• Last updated: 2015-06-25