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NCT04123899

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
Dong-A ST Co., Ltd.·ClinicalTrials.gov·drug
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Gastroduodenal Ulcer
Drug/Device/Intervention
IGAD→GSTD
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Dong-A ST Co., Ltd.
Timeline & enrollment
Phase
N/A
Start date
Oct 11, 2019
End date
Jan 03, 2020
Enrollment
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 ulcerGastrojejunal ulcerGastric ulcer : chronic or unspecified with haemorrhageGastrojejunal ulcer : chronic or unspecified with haemorrhageGastrojejunal ulcer : unspecified as acute or chronic, without haemorrhage or perforation
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04123899
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.