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NCT02481583

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

Completed Phase 1 Last updated 24 June 2015
What this trial tests

Phase 1 trial testing Levosulpiride in Dyspepsia in 42 participants. Completed in 1 May 2013.

Timeline
1 March 2013
Primary endpoint
1 May 2013
1 May 2013

Quick facts

Lead sponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment42
Start date1 March 2013
Primary completion1 May 2013
Estimated completion1 May 2013

Drugs / interventions tested

Conditions studied

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Who can join

Adults 19 to 45, any sex, with Dyspepsia. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Tolerability and Pharmacokinetic Comparison of Oral, Intramuscular, and Intravenous Administration of Levosulpiride After Single and Multiple Dosing in Healthy Chinese Volunteers.
    Xu M, Zhou Y, Ni Y, He X, et al · · 2015 · cited 10× · PMID 26404395 · DOI 10.1016/j.clinthera.2015.08.024

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Other trials of Levosulpiride

Trials testing the same drug.

Other recruiting trials for Dyspepsia

Currently open trials in the same condition.

Other Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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