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BE Study of Gaster®D Tab 20mg (Manufacturer Changed)

Primary Purpose

Gastroduodenal Ulcer

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

IGAD→GSTD

GSTD→IGAD

About this trial

This is an interventional treatment trial for Gastroduodenal Ulcer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
Female patients who were confirmed to be not pregnant at medical examination

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:
- 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

IGAD→GSTD

GSTD→IGAD

Arm Description

IGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)"

Outcomes

Primary Outcome Measures

AUClast

Area Under the plasma Concentration versus time curve(AUClast) of Famotidine

Cmax

Peak Plasma Concentration(Cmax) of Famotidine

Secondary Outcome Measures

Full Information

NCT ID

NCT04123899

First Posted

October 9, 2019

Last Updated

October 10, 2019

Sponsor

Dong-A ST Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04123899

Brief Title

BE Study of Gaster®D Tab 20mg (Manufacturer Changed)

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 11, 2019 (Anticipated)

Primary Completion Date

November 21, 2019 (Anticipated)

Study Completion Date

January 3, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A ST Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroduodenal Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IGAD→GSTD

Arm Type

Experimental

Arm Description

IGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)"

Arm Title

GSTD→IGAD

Arm Type

Experimental

Arm Description

IGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)"

Intervention Type

Drug

Intervention Name(s)

IGAD→GSTD

Intervention Description

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)"

Intervention Type

Drug

Intervention Name(s)

GSTD→IGAD

Intervention Description

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)"

Primary Outcome Measure Information:

Title

AUClast

Description

Area Under the plasma Concentration versus time curve(AUClast) of Famotidine

Time Frame

Before administration ~ 24hr

Title

Cmax

Description

Peak Plasma Concentration(Cmax) of Famotidine

Time Frame

Before administration ~ 24hr

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Female patients who were confirmed to be not pregnant at medical examination 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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

SeungHyun Kang, Ph.D

Phone

082-70-4665-9490

juspa@naver.com

12. IPD Sharing Statement

Learn more about this trial

BE Study of Gaster®D Tab 20mg (Manufacturer Changed)

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