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Pharmacokinetic Study of Levosulpiride

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ClinicalTrials.gov Identifier: NCT02481583
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Weiyong Li, Wuhan Union Hospital, China

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Drug: Levosulpiride Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Tolerability and Pharmacokinetic Comparison of Oral, Intramuscular and Intravenous Administration of Levosulpiride After Single and Multiple Doses in Fasting Healthy Chinese Volunteers
Study Start Date : March 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: part 1
12 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.
Drug: Levosulpiride
different formulations of levosulpiride

Experimental: part 2
30 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).
Drug: Levosulpiride
different formulations of levosulpiride




Primary Outcome Measures :
  1. Cmax [ Time Frame: two days ]
    Peak concentration

  2. Area under the curve-AUC [ Time Frame: two days ]
    Area under the curve - plasma concentration

  3. Clearance-CL [ Time Frame: two days ]
    Clearance

  4. Apparent volume of distribution-V [ Time Frame: two days ]
    The apparent volume of distribution


Secondary Outcome Measures :
  1. Safety (adverse events) [ Time Frame: one month ]
    adverse events



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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481583


Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
Principal Investigator: Weiyong Li HUST/Union Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Weiyong Li, vice director of the pharmacy department, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT02481583     History of Changes
Other Study ID Numbers: WHXH-Levosul
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by Weiyong Li, Wuhan Union Hospital, China:
levosulpiride
pharmacokinetics
adverse effects
bioavailability

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Sulpiride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents