Gastroduodenal UlcerNCT04123899
BE Study of Gaster®D Tab 20mg (Manufacturer Changed)
A study testing IGAD→GSTD and GSTD→IGAD in people with Gastroduodenal Ulcer, run by Dong-A ST Co., Ltd..
Trial summary
An Open-Label, Randomized, Two-sequence, Two-period, Fasting Condition, Single Oral Dose, Cross-over Study of Bioequivalence of "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" and "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" in Healthy, Adult, Human Subjects. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroduodenal Ulcer
- What is being tested?
- IGAD→GSTD and GSTD→IGAD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 11 Oct 2019to 3 Jan 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A person who aged 19 or older at the time of screening
- No congenital or chronic diseases or pathological symptoms on screening
- A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
- BMI of 18 to 30 (BMI calculation: kg/m2)
- No history of gastrointestinal resection that may affect the absorption of drugs
- No medical history of mental illness within five years prior to screening
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- A person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature
- A person who is willing and able to follow all scheduled hospitalization and outpatient visits, medications, clinical laboratory examination and the terms of compliance
- Female patients who were confirmed to be not pregnant at medical examination
Who cannot join
- A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to first administration of the IP
- A person who uses drugs that can affect the study within 10 days before first administration of the IP
- A person who is considered unsuitable to participate in the study by the investigator
- A person who has participated in other clinical trials within 6 months prior to the first administration of the IP
- A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before first administration of IP
- A person who is hypersensitive to venipuncture
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- A person with a history of regular alcohol intake within six months prior to screening:
- Women: More than 14 glasses/week
- Men: More than 21 glasses/week (1 shot: 50 ml of soju, 30 ml of spirits, 250 ml of beer)
- Blood AST (GOT) or ALT (GPT) levels exceed the upper reference range limit by 2 times or γ-GTP levels exceed the upper reference range limit by 1.5 times
- Hypersensitive to any of the IP components
- Patient with hereditary disease Phenylketonuria who need to regulate their intake of phenylalanine
- Lactating women
- A person who does not agree to exclude the possibility of pregnancy using the contraception from the date of the first administration of the IP until the 7th day after the last administration.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-Label, Randomized, Two-sequence, Two-period, Fasting Condition, Single Oral Dose, Cross-over Study of Bioequivalence of "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" and "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" in Healthy, Adult, Human Subjects
An Open-Label, Randomized, Two-sequence, Two-period, Fasting Condition, Single Oral Dose, Cross-over Study of Bioequivalence of "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" and "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" in Healthy, Adult, Human Subjects.
Read the detailed description
- Study design: An open-Label, randomized, two-sequence, two-period, fasting condition, single oral dose, cross-over study
- Administration method: The subject should maintain a minimum of 10 hours of empty stomach before administration, and swallow an oral dose of 1 tablets (Famotidine 20 mg) after moistening mouth with 20 mL of water and dissolving completely with saliva on the tongue without water at around 8 a.m. on the day of the test at room temperature. The subject should not chew the drug or break it, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the collection time.
- Wash out period: 7 days
- Blood collection time: Before the administration, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hr after the administration (total 13 times)
- Analysis: Measurement of the concentration of an unchangeable substance of Famotidine in plasma
- Conditions
- Gastroduodenal Ulcer
- Being tested
- IGAD→GSTD, GSTD→IGAD
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGAD→GSTDDrug
Drug: IGAD First Period: Single oral administration of 1 tablet of "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)"
Other: Washout period 7 days
Drug: GSTD Second Period: Single oral administration of 1 tablet of "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)"
GSTD→IGADDrug
Drug: GSTD First Period: Single oral administration of 1 tablet of "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)"
Other: Washout period 7 days
Drug: IGAD Second Period: Single oral administration of 1 tablet of "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)"
| Study group | Role | What they receive |
|---|---|---|
| IGAD→GSTD | Experimental | IGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" Receives: Drug: IGAD→GSTD |
| GSTD→IGAD | Experimental | IGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" Receives: Drug: GSTD→IGAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
Area Under the plasma Concentration versus time curve(AUClast) of Famotidine
Measured: Before administration ~ 24hr
Cmax
Peak Plasma Concentration(Cmax) of Famotidine
Measured: Before administration ~ 24hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start11 Oct 2019 (estimated)
- Primary completion21 Nov 2019 (estimated)
- Study completion3 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroduodenal UlcerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123899
- Sponsor's protocol ID
- BIBE2019-19
- Status last verified
- Oct 2019
- First submitted
- 9 Oct 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Two-sequence, Two-period, Fasting Condition, Single Oral Dose, Cross-over Study of Bioequivalence of "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" and "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" in Healthy, Adult, Human Subjects
- ClinicalTrials.gov ID
- NCT04123899
- Acronym / sponsor ID
- BIBE2019-19
- Conditions
- Gastroduodenal Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2019 (estimated)
- Primary completion
- 21 Nov 2019 (estimated)
- Study completion
- 3 Jan 2020 (estimated)
- First posted
- 11 Oct 2019 (actual)
- 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, Two-sequence, Two-period, Fasting Condition, Single Oral Dose, Cross-over Study of Bioequivalence of "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" and "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" in Healthy, Adult, Human Subjects.
Detailed description
- Study design: An open-Label, randomized, two-sequence, two-period, fasting condition, single oral dose, cross-over study
- Administration method: The subject should maintain a minimum of 10 hours of empty stomach before administration, and swallow an oral dose of 1 tablets (Famotidine 20 mg) after moistening mouth with 20 mL of water and dissolving completely with saliva on the tongue without water at around 8 a.m. on the day of the test at room temperature. The subject should not chew the drug or break it, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the collection time.
- Wash out period: 7 days
- Blood collection time: Before the administration, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hr after the administration (total 13 times)
- Analysis: Measurement of the concentration of an unchangeable substance of Famotidine in plasma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGAD→GSTD | Experimental | Drug: IGAD→GSTDIGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" |
| GSTD→IGAD | Experimental | Drug: GSTD→IGADIGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A person who aged 19 or older at the time of screening
- No congenital or chronic diseases or pathological symptoms on screening
- A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
- BMI of 18 to 30 (BMI calculation: kg/m2)
- No history of gastrointestinal resection that may affect the absorption of drugs
Key exclusion criteria (14 listed)
- A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to first administration of the IP
- A person who uses drugs that can affect the study within 10 days before first administration of the IP
- A person who is considered unsuitable to participate in the study by the investigator
- A person who has participated in other clinical trials within 6 months prior to the first administration of the IP
- A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before first administration of IP
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 |
|---|---|---|
| IGAD→GSTDDrug: IGAD First Period: Single oral administration of 1 tablet of "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" Other: Washout period 7 days Drug: GSTD Second Period: Single oral administration of 1 tablet of "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" | Drug | IGAD→GSTD |
| GSTD→IGADDrug: GSTD First Period: Single oral administration of 1 tablet of "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" Other: Washout period 7 days Drug: IGAD Second Period: Single oral administration of 1 tablet of "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" | Drug | GSTD→IGAD |
Primary outcome
AUClast
Time frame: Before administration ~ 24hr
Area Under the plasma Concentration versus time curve(AUClast) of Famotidine
Cmax
Time frame: Before administration ~ 24hr
Peak Plasma Concentration(Cmax) of Famotidine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
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.
Questions about this trial
What is this clinical trial studying?
A study testing IGAD→GSTD and GSTD→IGAD in people with Gastroduodenal Ulcer, run by Dong-A ST Co., Ltd..
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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 11 Oct 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SeungHyun Kang, Ph.D (082-70-4665-9490, juspa@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUClast (time frame: Before administration ~ 24hr). 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 11 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.