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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGAD→GSTD | Experimental | IGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" |
|
| GSTD→IGAD | Experimental | IGAD: "Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)" GSTD: "Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGAD→GSTD | Drug | 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)" |
| 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 |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SeungHyun Kang, Ph.D | Contact | 082-70-4665-9490 | juspa@naver.com |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| GSTD→IGAD | Drug | 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)" |
|
| D013272 | Stomach Diseases |