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

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ClinicalTrials.gov Identifier: NCT04123899
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Gastroduodenal Ulcer Drug: IGAD→GSTD Drug: GSTD→IGAD Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 11, 2019
Estimated Primary Completion Date : November 21, 2019
Estimated Study Completion Date : January 3, 2020

Resource links provided by the National Library of Medicine


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)"





Primary Outcome Measures :
  1. AUClast [ Time Frame: Before administration ~ 24hr ]
    Area Under the plasma Concentration versus time curve(AUClast) of Famotidine

  2. Cmax [ Time Frame: Before administration ~ 24hr ]
    Peak Plasma Concentration(Cmax) of Famotidine



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123899


Contacts
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Contact: SeungHyun Kang, Ph.D 082-70-4665-9490 juspa@naver.com

Sponsors and Collaborators
Dong-A ST Co., Ltd.

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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT04123899     History of Changes
Other Study ID Numbers: BIBE2019-19
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs