Gastric UlcerPhase 1NCT02759224
A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet
A Phase 1 study testing BRI-1501, Lafutidine and Irsogladine maleate in people with Gastric Ulcer, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual Tablets in Healthy Adult Volunteers Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Ulcer
- What is being tested?
- BRI-1501, Lafutidine and Irsogladine maleate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Apr 2016to 29 Dec 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject, aged 19- 50 years
Who cannot join
- History of clinically significant and active disease
- History of gastrointestinal disease
- History of clinically significant hypersensitivity to study drug, any other drug
- Laboratory test serum AST or ALT > 1.25 times of upper normal range serum total bilirubin > 1.5 times of upper normal range eGFR < 60 ml/min/1.73m² serological test(HBsAg, HCV Ab, HIV Ag/Ab, Syphilis reagin) positive
- Hypotension or hypertension
- Pregnant or nursing women
- Participation in any other study within 90 days
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul
About this study
An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual Tablets in Healthy Adult Volunteers
- Conditions
- Gastric Ulcer
- Being tested
- BRI-1501, Lafutidine, Irsogladine maleate
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRI-1501Drug
LafutidineDrug
Irsogladine maleateDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Lafutidine and Irsogladine maleate --> BRI-1501) | Other | Subjects of Arm A take Lafutidine and Irsogladine maleate Individual tablets at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm A take a BRI-1501 tablet at 36th day Receives: Drug: BRI-1501; Drug: Lafutidine; Drug: Irsogladine maleate |
| Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate) | Other | Subjects of Arm B take a BRI-1501 tablet at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm B take Lafutidine and Irsogladine maleate Individual tablets at 36th day Receives: Drug: BRI-1501; Drug: Lafutidine; Drug: Irsogladine maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate
Measured: 0~36 hour after medication
Area under the plasma drug concentration-time curve(AUClast) of Lafutidine and Irsogladine maleate
Measured: 0~36 hour after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start15 Apr 2016
- Primary completion1 Jul 2016
- Study completion29 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UlcerStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759224
- Sponsor's protocol ID
- BR-LIC-CT-101
- Status last verified
- Feb 2017
- First submitted
- 21 Apr 2016
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet
- ClinicalTrials.gov ID
- NCT02759224
- Acronym / sponsor ID
- BR-LIC-CT-101
- Conditions
- Gastric Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 29 Dec 2016 (actual)
- First posted
- 3 May 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.
An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual Tablets in Healthy Adult Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Lafutidine and Irsogladine maleate --> BRI-1501) | Other | Drug: BRI-1501, Drug: Lafutidine, Drug: Irsogladine maleateSubjects of Arm A take Lafutidine and Irsogladine maleate Individual tablets at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm A take a BRI-1501 tablet at 36th day |
| Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate) | Other | Drug: BRI-1501, Drug: Lafutidine, Drug: Irsogladine maleateSubjects of Arm B take a BRI-1501 tablet at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm B take Lafutidine and Irsogladine maleate Individual tablets at 36th day |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subject, aged 19- 50 years
Key exclusion criteria (7 listed)
- History of clinically significant and active disease
- History of gastrointestinal disease
- History of clinically significant hypersensitivity to study drug, any other drug
- Laboratory test serum AST or ALT > 1.25 times of upper normal range serum total bilirubin > 1.5 times of upper normal range eGFR < 60 ml/min/1.73m² serological test(HBsAg, HCV Ab, HIV Ag/Ab, Syphilis reagin) positive
- Hypotension or hypertension
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 |
|---|---|---|
| BRI-1501 | Drug | Arm A (Lafutidine and Irsogladine maleate --> BRI-1501), Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate) |
| Lafutidine | Drug | Arm A (Lafutidine and Irsogladine maleate --> BRI-1501), Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate) |
| Irsogladine maleate | Drug | Arm A (Lafutidine and Irsogladine maleate --> BRI-1501), Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate) |
Primary outcome
Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate
Time frame: 0~36 hour after medication
Area under the plasma drug concentration-time curve(AUClast) of Lafutidine and Irsogladine maleate
Time frame: 0~36 hour after medication
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 7 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BRI-1501, Lafutidine and Irsogladine maleate in people with Gastric Ulcer, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
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 1 inclusion and 7 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 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate (time frame: 0~36 hour after medication). The study lists 2 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 7 Feb 2017.