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
1 other identifier
interventional
42
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2013
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 25, 2015
CompletedJune 25, 2015
June 1, 2015
2 months
May 9, 2015
June 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Cmax
Peak concentration
two days
Area under the curve-AUC
Area under the curve - plasma concentration
two days
Clearance-CL
Clearance
two days
Apparent volume of distribution-V
The apparent volume of distribution
two days
Secondary Outcomes (1)
Safety (adverse events)
one month
Study Arms (2)
part 1
EXPERIMENTAL12 subjects successively received a single dose of levosulpiride tablets 25, 50, or 100 mg via oral administration and 50-mg of levosulpiride tablets 3 times a day for 7 days.
part 2
EXPERIMENTAL30 subjects were randomly assigned to 1 of 3 treatment groups (25, 50, or 75 mg) via i.m. administration, the 50-mg group subjects also received levosulpiride by i.v. route and repeated administration by i.m. route (twice a day for 3 days).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Xu M, Zhou Y, Ni Y, He X, Li H, Sattar H, Chen H, Li W. Tolerability and Pharmacokinetic Comparison of Oral, Intramuscular, and Intravenous Administration of Levosulpiride After Single and Multiple Dosing in Healthy Chinese Volunteers. Clin Ther. 2015 Nov 1;37(11):2458-67. doi: 10.1016/j.clinthera.2015.08.024. Epub 2015 Sep 26.
PMID: 26404395DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weiyong Li
HUST/Union Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice director of the pharmacy department
Study Record Dates
First Submitted
May 9, 2015
First Posted
June 25, 2015
Study Start
March 1, 2013
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
June 25, 2015
Record last verified: 2015-06