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

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 Overview

• Status: Unknown
• Conditions: Gastroduodenal Ulcer
• Intervention / Treatment: Drug: IGAD→GSTD; Drug: GSTD→IGAD

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 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.

3. Wash out period: 7 days
4. 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)
5. Analysis: Measurement of the concentration of an unchangeable substance of Famotidine in plasma

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SeungHyun Kang, Ph.D; Phone Number: 082-70-4665-9490; Email: juspa@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. A person who aged 19 or older at the time of screening
2. No congenital or chronic diseases or pathological symptoms on screening
3. A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
4. BMI of 18 to 30 (BMI calculation: kg/m2)
5. No history of gastrointestinal resection that may affect the absorption of drugs
6. No medical history of mental illness within five years prior to screening
7. 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
8. A person who is willing and able to follow all scheduled hospitalization and outpatient visits, medications, clinical laboratory examination and the terms of compliance
9. Female patients who were confirmed to be not pregnant at medical examination

Exclusion Criteria:

1. 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
2. A person who uses drugs that can affect the study within 10 days before first administration of the IP
3. A person who is considered unsuitable to participate in the study by the investigator
4. A person who has participated in other clinical trials within 6 months prior to the first administration of the IP
5. A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before first administration of IP
6. A person who is hypersensitive to venipuncture

7. 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)
8. 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
9. Hypersensitive to any of the IP components
10. Patient with hereditary disease Phenylketonuria who need to regulate their intake of phenylalanine
11. Lactating women
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IGAD→GSTD; IGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)"	Drug: IGAD→GSTD; 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)"
Experimental: GSTD→IGAD; IGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)"	Drug: GSTD→IGAD; 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)"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 11, 2019
• Primary Completion (Anticipated): November 21, 2019
• Study Completion (Anticipated): January 3, 2020

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Peptic Ulcer
• Other Study ID Numbers: BIBE2019-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No