Peptic UlcerPhase 1NCT02581696
The Drug-drug Interaction and Safety of Lafutidine and Irsogladine Maleate in Healthy Adult Volunteers
A Phase 1 study testing Lafutidine and Irsogladine maleate in people with Peptic Ulcer, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
An open-label, multiple-dose, single-arm, phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate 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
- Peptic Ulcer
- What is being tested?
- 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
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Nov 2015
- 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 subjects between the ages of 19 and 50 at the screening
- Male subjects whose weight is greater than 55kg Female subjects whose weight is greater than 50kg and within ±20% range of ideal body weight.
- Ideal body weight(kg) = (Height(cm) - 100) 0.9
- For female subjects must show negative for urine pregnancy test and also must meet one of the below listed criteria:
- A menopausal woman (Menstruation should stop at least 2 years ago)
- Take sterilization operation (Hysterectomy, Ovariotomy, Tubal ligation, any other operation)
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- Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subject.
- Before 3 months of the screening and 1month after the end of drug administration, subjects must meet contraception requirements.
- For avoiding the drug-drug interaction, subjects must not use any contraceptive drugs and must choose abstinence or use physical block.
- A sexually active male subjects must use and accepted method of contraception during the course of the clinical study and must not donate sperms until a month after finishing drug administration. (If male subjects oneself or female partner is sterility, that does not apply.)
- Subjects who understand the clinical study completely, agree to participate and sign written consent form for conduct precautions
Who cannot join
- Subjects having liver system disorders, kidney disorders, digestive system disorders, cardiovascular disorders, respiratory disorders, endocrine disorders, neurological disorder or hematological disorders, psychiatric disorders, or a history of malignancy, disorders
- Subjects having a history of gastrointestinal system disorders influencing drug absorption(i.e, Crohn's disease, ulcer) or surgery (except simple typhlectomy or hernia repair surgery)
- Subjects having a history of hypersensitivity to additional ingredient or clinically significant hypersensitivity to lafutidine and Irsogladine or any other drug.
- Subjects who judged for inappropriate to physical examination. ( Disease history, physical examine, vital sign, EKG examine, laboratory examine and so on ).
- Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption and any other hereditary disorder.
- Subjects who is sitting after 5minutes break, having Systolic blood pressure ≥ 140 mmHg and Diastolic blood pressure ≤ 90 mmHg, or Systolic blood pressure ≥ 90 mmHg and Diastolic blood pressure ≤ 60 mmHg on vital sign
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- Subjects having a history of drug abuse or positive drug abuse urinalysis testing at screening.
- Subjects who is pregnancy or feed breast milk.
- Subjects who has participated in another clinical study before study drug administration Subjects having blood donation within two months or component blood donation within one month before study drug administration
- Subjects who has drunken beverages caffeine-containing or alcohol or smoking during prohibition period
- Subjects who has judged to be inappropriate for this study by investigators according to other reasons including clinical lab test result
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
Official title: An Open-label, Multiple-dose, Single-arm, Phase 1 Study to Evaluate the Drug-drug Interaction and Safety of Lafutidine and Irsogladine Maleate in Healthy Adult Volunteers
An open-label, multiple-dose, single-arm, phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers
Read the detailed description
A phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers. Subjects judged to be appropriate to this study by screening before 28days of first administration. Subjects administrate Lafutidine bid during period I. After wash-out period, administrate Irsogladine maleate qd during Period II. After than, coadministration Lafutidine bid and Irsogladine maleate qd.
- Conditions
- Peptic Ulcer
- Being tested
- Lafutidine, Irsogladine maleate
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LafutidineDrug
Also called STOGAR
Lafutidine 10mg, 1 tablet, bid
Irsogladine maleateDrug
Also called STOWON
Irsogladine maleate 2mg, 2 tablet, qd
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | This is a follow-up study of BR-LAF-CT-101, a phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers. Subjects judged to be appropriate to this study by screening. Receives: Drug: Lafutidine; Drug: Irsogladine maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve of Lafutidine and Irsogladine maleate
Measured: Sampling time 1, 19, 21days before drug administration, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hr after drug administration. (total 24times)
Secondary outcomes (1)
Peak Plasma Concentration of Lafutidine and Irsogladine
Measured: Sampling time 1, 19, 21days before drug administration, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hr after drug administration. (total 24times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea
- Responsible party
- Sponsor
- Investigators
- Seoung-hun Han, Professor, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581696
- Sponsor's protocol ID
- BR-LAF-CT-101
- Status last verified
- Feb 2017
- First submitted
- 12 Oct 2015
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dose, Single-arm, Phase 1 Study to Evaluate the Drug-drug Interaction and Safety of Lafutidine and Irsogladine Maleate in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02581696
- Acronym / sponsor ID
- BR-LAF-CT-101
- Conditions
- Peptic Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Oct 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.
An open-label, multiple-dose, single-arm, phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers
Detailed description
A phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers. Subjects judged to be appropriate to this study by screening before 28days of first administration. Subjects administrate Lafutidine bid during period I. After wash-out period, administrate Irsogladine maleate qd during Period II. After than, coadministration Lafutidine bid and Irsogladine maleate qd.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: Lafutidine, Drug: Irsogladine maleateThis is a follow-up study of BR-LAF-CT-101, a phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers. Subjects judged to be appropriate to this study by screening. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy subjects between the ages of 19 and 50 at the screening
- Male subjects whose weight is greater than 55kg Female subjects whose weight is greater than 50kg and within ±20% range of ideal body weight.
- Ideal body weight(kg) = (Height(cm) - 100) 0.9
- For female subjects must show negative for urine pregnancy test and also must meet one of the below listed criteria:
- A sexually active male subjects must use and accepted method of contraception during the course of the clinical study and must not donate sperms until a month after finishing drug administration. (If male subjects oneself or female partner is sterility, that does not apply.)
Key exclusion criteria (11 listed)
- Subjects having liver system disorders, kidney disorders, digestive system disorders, cardiovascular disorders, respiratory disorders, endocrine disorders, neurological disorder or hematological disorders, psychiatric disorders, or a history of malignancy, disorders
- Subjects having a history of gastrointestinal system disorders influencing drug absorption(i.e, Crohn's disease, ulcer) or surgery (except simple typhlectomy or hernia repair surgery)
- Subjects having a history of hypersensitivity to additional ingredient or clinically significant hypersensitivity to lafutidine and Irsogladine or any other drug.
- Subjects who judged for inappropriate to physical examination. ( Disease history, physical examine, vital sign, EKG examine, laboratory examine and so on ).
- Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption and any other hereditary disorder.
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 |
|---|---|---|
| LafutidineAlso: STOGARLafutidine 10mg, 1 tablet, bid | Drug | Single arm |
| Irsogladine maleateAlso: STOWONIrsogladine maleate 2mg, 2 tablet, qd | Drug | Single arm |
Primary outcome
Area under the plasma concentration versus time curve of Lafutidine and Irsogladine maleate
Time frame: Sampling time 1, 19, 21days before drug administration, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hr after drug administration. (total 24times)
1 secondary outcome
Peak Plasma Concentration of Lafutidine and Irsogladine
Time frame: Sampling time 1, 19, 21days before drug administration, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hr after drug administration. (total 24times)
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 6 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Seoung-hun Han, Professor principal investigator
The Catholic University of Korea
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 Lafutidine and Irsogladine maleate in people with Peptic 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 11 inclusion and 11 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 6 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?
Area under the plasma concentration versus time curve of Lafutidine and Irsogladine maleate (time frame: Sampling time 1, 19, 21days before drug administration, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hr after drug administration. (total 24times)). 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 6 Feb 2017.