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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Gastroduodenal Ulcer

Interventions

Type	Name	Description
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)"

Timeline

• Start date: 2019-10-11
• Primary completion: 2019-11-21
• Completion: 2020-01-03
• First posted: 2019-10-11
• Last updated: 2019-10-11