Gastroduodenal Ulcer Clinical Trial
Official title:
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
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.
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
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