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BE Study of Gaster®D Tab 20mg (Manufacturer Changed) - Trial NCT04123899

Access comprehensive clinical trial information for NCT04123899 through Pure Global AI's free database. This phase not specified trial is sponsored by Dong-A ST Co., Ltd. and is currently status unknown. The study focuses on Gastroduodenal Ulcer. Target enrollment is 32 participants.

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NCT04123899
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Trial Details
ClinicalTrials.gov • NCT04123899
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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

Study Focus

Gastroduodenal Ulcer

IGAD→GSTD

Interventional

drug

Sponsor & Location

Dong-A ST Co., Ltd.

Timeline & Enrollment

N/A

Oct 11, 2019

Jan 03, 2020

32 participants

Primary Outcome

AUClast,Cmax

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.

ICD-10 Classifications

Gastric ulcer
Gastrojejunal ulcer
Gastric ulcer : chronic or unspecified with haemorrhage
Gastrojejunal ulcer : chronic or unspecified with haemorrhage
Gastrojejunal ulcer : unspecified as acute or chronic, without haemorrhage or perforation

Data Source

ClinicalTrials.gov

NCT04123899

Non-Device Trial