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 range19 Years

SexALL

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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
✕. 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

What they're measuring

AUClast

Timeframe: Before administration ~ 24hr

Cmax

Timeframe: Before administration ~ 24hr

Trial details

NCT IDNCT04123899

SponsorDong-A ST Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-21

Contact for this trial

SeungHyun Kang, Ph.D

082-70-4665-9490 juspa@naver.com

View on ClinicalTrials.gov More Gastroduodenal Ulcer trials