Status:
UNKNOWN
BE Study of Gaster®D Tab 20mg (Manufacturer Changed)
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Gastroduodenal Ulcer
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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...
Detailed Description
1. Study design: An open-Label, randomized, two-sequence, two-period, fasting condition, single oral dose, cross-over study 2. Administration method: The subject should maintain a minimum of 10 ho...
Eligibility Criteria
Inclusion
- 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
- Female patients who were confirmed to be not pregnant at medical examination
Exclusion
- 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:
- 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.
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 3 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04123899
Start Date
October 11 2019
End Date
January 3 2020
Last Update
October 11 2019
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