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

NCT04123899 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-10-11

No results posted yet for this study

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.

Conditions

  • Gastroduodenal Ulcer

Interventions

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)"

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)"

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-11
Primary Completion
2019-11-21
Completion
2020-01-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04123899 on ClinicalTrials.gov