BE Study of Gaster®D Tab 20mg (Manufacturer Changed) (NCT04123899) | Clinical Trial Compass
UnknownNot Applicable
BE Study of Gaster®D Tab 20mg (Manufacturer Changed)
32 participantsStarted 2019-10-11
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. A person with a history of regular alcohol intake within six months prior to screening:
. 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