Chronic GastritisPhase 1NCT02658864
Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets
A Phase 1 study testing lafutidine in people with Chronic Gastritis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
This study was to evaluate the pharmacokinetics of single and multiple doses of oral lafutidine tablets and the effect of food on pharmacokinetics in healthy Chinese subjects. The tolerability and the effect of sex on the pharmacokinetic properties were also evaluated to acquire more pharmacokinetic information. Read more about this study
- Who is it for?
- Ages 19 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Gastritis
- What is being tested?
- lafutidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jun 2005
- 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 27 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: Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets in Healthy Chinese Subjects
This study was to evaluate the pharmacokinetics of single and multiple doses of oral lafutidine tablets and the effect of food on pharmacokinetics in healthy Chinese subjects. The tolerability and the effect of sex on the pharmacokinetic properties were also evaluated to acquire more pharmacokinetic information.
Read the detailed description
The study of single-dose was randomized, three-period, crossover. And in this study, 12 subjects were randomly assigned to 3 dose groups and received a single dose of 10mg, 20mg and 40mg lafutidine tablets. The washout period was 7 calendar days. In the multiple-dose, 12 subjects took lafutidine tablets of 10 mg twice a day for 6 consecutive days. In the food-effect study, 12 subjects were randomly assigned to 2 groups. One group received a single dose of 10mg lafutidine tablets under fasted condition, while the other were in fed condition. The drug administrations were separated by a wash-out period of seven calendar days. In each study group, the male and the female are both in half of the subjects. Using a liquid chromatography tandem mass spectrometry (LC/MS/MS) method to determine the plasma concentration of lafutidine. Pharmacokinetic parameters were calculated using the single compartment model.
- Conditions
- Chronic Gastritis
- Being tested
- lafutidine
- Keywords
- lafutidine tablet, pharmacokinetics, food, safety, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lafutidineDrug
comparison of different doses, sex and medication conditions
| Study group | Role | What they receive |
|---|---|---|
| 10-mg group | Experimental | Twelve healthy subjects were administered a single oral dose of 10 mg lafutidine tablets in fasted state. Receives: Drug: lafutidine |
| 20-mg group | Experimental | Twelve healthy subjects were administered a single oral dose of 20 mg lafutidine tablets in fasted state. Receives: Drug: lafutidine |
| 40-mg group | Experimental | Twelve healthy subjects were administered a single oral dose of 40 mg lafutidine tablets in fasted state. Receives: Drug: lafutidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak concentration
Measured: one day
Area under the curve
Area under the curve - plasma concentration
Measured: one day
Clearance
Clearance
Measured: one day
Apparent volume of distribution-V
The apparent volume of distribution
Measured: one day
Secondary outcomes (1)
Safety (adverse events)
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startApr 2005
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic GastritisStudies 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
- 12 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, PhD, Principal investigator, HUST/Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658864
- Sponsor's protocol ID
- WHXH-lafutidine
- Status last verified
- Jan 2016
- First submitted
- 15 Jan 2016
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT02658864
- Acronym / sponsor ID
- WHXH-lafutidine
- Conditions
- Chronic Gastritis
- Keywords
- lafutidine tablet, pharmacokinetics, food, safety, healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 20 Jan 2016 (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.
This study was to evaluate the pharmacokinetics of single and multiple doses of oral lafutidine tablets and the effect of food on pharmacokinetics in healthy Chinese subjects. The tolerability and the effect of sex on the pharmacokinetic properties were also evaluated to acquire more pharmacokinetic information.
Detailed description
The study of single-dose was randomized, three-period, crossover. And in this study, 12 subjects were randomly assigned to 3 dose groups and received a single dose of 10mg, 20mg and 40mg lafutidine tablets. The washout period was 7 calendar days. In the multiple-dose, 12 subjects took lafutidine tablets of 10 mg twice a day for 6 consecutive days. In the food-effect study, 12 subjects were randomly assigned to 2 groups. One group received a single dose of 10mg lafutidine tablets under fasted condition, while the other were in fed condition. The drug administrations were separated by a wash-out period of seven calendar days. In each study group, the male and the female are both in half of the subjects. Using a liquid chromatography tandem mass spectrometry (LC/MS/MS) method to determine the plasma concentration of lafutidine. Pharmacokinetic parameters were calculated using the single compartment model.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10-mg group | Experimental | Drug: lafutidineTwelve healthy subjects were administered a single oral dose of 10 mg lafutidine tablets in fasted state. |
| 20-mg group | Experimental | Drug: lafutidineTwelve healthy subjects were administered a single oral dose of 20 mg lafutidine tablets in fasted state. |
| 40-mg group | Experimental | Drug: lafutidineTwelve healthy subjects were administered a single oral dose of 40 mg lafutidine tablets in fasted state. |
Who may qualify
- Ages
- 19 to 27 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 |
|---|---|---|
| lafutidinecomparison of different doses, sex and medication conditions | Drug | 10-mg group, 20-mg group, 40-mg group |
Primary outcome
Cmax
Time frame: one day
Peak concentration
Area under the curve
Time frame: one day
Area under the curve - plasma concentration
Clearance
Time frame: one day
Clearance
Apparent volume of distribution-V
Time frame: one day
The apparent volume of distribution
1 secondary outcome
Safety (adverse events)
Time frame: six weeks
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 20 Jan 2016.
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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, PhD principal investigator
HUST/Union Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lafutidine in people with Chronic Gastritis, 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 20 Jan 2016. 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: one day). 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?
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 20 Jan 2016.