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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
Phase 1 trial testing Levosulpiride in Dyspepsia in 42 participants. Completed in 1 May 2013.
1 May 2013
Quick facts
| Lead sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 42 |
| Start date | 1 March 2013 |
| Primary completion | 1 May 2013 |
| Estimated completion | 1 May 2013 |
Drugs / interventions tested
- Levosulpiride (LEVOSULPIRIDE) — full drug profile →
Conditions studied
- Dyspepsia — all drugs for Dyspepsia →
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.
-
Cmax
Time frame: two days
Peak concentration -
Area under the curve-AUC
Time frame: two days
Area under the curve - plasma concentration -
Clearance-CL
Time frame: two days
Clearance -
Apparent volume of distribution-V
Time frame: two days
The apparent volume of distribution
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):
-
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
Verify or expand the search:
- PubMed search for NCT02481583
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Levosulpiride
Trials testing the same drug.
- NCT04697641 — Helicobacter Pylori Eradication in Functional Dyspepsia · NA · completed
Other recruiting trials for Dyspepsia
Currently open trials in the same condition.
- NCT06941545 — High Resolution Gastric Mapping and Gastroduodenal Manometry · NA · recruiting
- NCT07261228 — The Difference in Carbon Footprint Between Diagnostic Upper GI Endoscopy in Dyspeptic Patients Versus Therapeutic Upper · recruiting
- NCT06755671 — A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms · recruiting
- NCT06422052 — Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspep · recruiting
- NCT05810168 — Traditional Dietary Advice Versus Low FODMAP Diet in Postprandial Functional Dyspepsia · NA · recruiting
Other Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials
Trials by the same sponsor.
- NCT07521124 — ABC Maintenance Therapy for AML · NA · not yet recruiting
- NCT07497243 — X-ray Assisted Diagnostic System · not yet recruiting
- NCT07520123 — Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatiti · NA · not yet recruiting
- NCT06970262 — FMT for Lung and Associated-organ Rescue Efficacy in ARDS Patients · NA · recruiting
- NCT07509424 — Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Lo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02481583 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Last refreshed: 24 June 2015
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