DyspepsiaPhase 1NCT02481583
Pharmacokinetic Study of Levosulpiride
A Phase 1 study testing Levosulpiride in people with Dyspepsia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Levosulpiride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: Tolerability and Pharmacokinetic Comparison of Oral, Intramuscular and Intravenous Administration of Levosulpiride After Single and Multiple Doses in Fasting Healthy Chinese Volunteers
The aim of this study was to characterise the pharmacokinetic properties and assess the safety of different formulations of levosulpiride in healthy Chinese volunteers.
Read the 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
- Being tested
- Levosulpiride
- Keywords
- levosulpiride, pharmacokinetics, adverse effects, bioavailability
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosulpirideDrug
different formulations of levosulpiride
| Study group | Role | What they receive |
|---|---|---|
| part 1 | Experimental | 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. Receives: Drug: Levosulpiride |
| part 2 | Experimental | 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). Receives: Drug: Levosulpiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak concentration
Measured: two days
Area under the curve-AUC
Area under the curve - plasma concentration
Measured: two days
Clearance-CL
Clearance
Measured: two days
Apparent volume of distribution-V
The apparent volume of distribution
Measured: two days
Secondary outcomes (1)
Safety (adverse events)
adverse events
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiyong Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Weiyong Li, Principal investigator, HUST/Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481583
- Sponsor's protocol ID
- WHXH-Levosul
- Status last verified
- Jun 2015
- First submitted
- 9 May 2015
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26404395
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Pharmacokinetic Comparison of Oral, Intramuscular and Intravenous Administration of Levosulpiride After Single and Multiple Doses in Fasting Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT02481583
- Acronym / sponsor ID
- WHXH-Levosul
- Conditions
- Dyspepsia
- Keywords
- levosulpiride, pharmacokinetics, adverse effects, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| part 1 | Experimental | Drug: Levosulpiride12 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 | Experimental | Drug: Levosulpiride30 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). |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levosulpiridedifferent formulations of levosulpiride | Drug | part 1, part 2 |
Primary outcome
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
1 secondary outcome
Safety (adverse events)
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Derived from this study: PubMed 26404395Xu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiyong Li principal investigator
HUST/Union Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levosulpiride in people with Dyspepsia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: two days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02481583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.