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

2019-10-17 11:03:45 | BioPortfolio

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.

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

Study Design

Conditions

Gastroduodenal Ulcer

Intervention

IGAD→GSTD, GSTD→IGAD

Status

Not yet recruiting

Source

Dong-A ST Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-17T11:03:45-0400

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