BE Study of Gaster®D Tab 20mg (Manufacturer Changed)
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
1 other identifier
interventional
32
0 countries
N/A
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 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" in Healthy, Adult, Human Subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2019
CompletedFirst Posted
Study publicly available on registry
October 11, 2019
CompletedStudy Start
First participant enrolled
October 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2020
CompletedOctober 11, 2019
October 1, 2019
1 month
October 9, 2019
October 10, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
AUClast
Area Under the plasma Concentration versus time curve(AUClast) of Famotidine
Before administration ~ 24hr
Cmax
Peak Plasma Concentration(Cmax) of Famotidine
Before administration ~ 24hr
Study Arms (2)
IGAD→GSTD
EXPERIMENTALIGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)"
GSTD→IGAD
EXPERIMENTALIGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)"
Interventions
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)"
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)"
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2019
First Posted
October 11, 2019
Study Start
October 11, 2019
Primary Completion
November 21, 2019
Study Completion
January 3, 2020
Last Updated
October 11, 2019
Record last verified: 2019-10