Gastric Ulcer Clinical Trial
Official title:
An Open Label, Randomised, Single Center, 2 Way Crossover Study to Assess Bioequivalence Between a Commercial HPMC Capsule of D961H 20 mg and a Pellets Based Sachet Formulation of D961H 20 mg by Pharmacodynamics (Intragastric pH) After Once-daily Repeated Oral Administration in Japanese Healthy Male Subjects
The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent
to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric
pH>4.
To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of
percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH.
To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.
To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20
mg.
The purpose of this study is; To investigate whether a pellets based sachet formulation of
D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20
mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of
time with intragastric pH>4 during 24 hours after dose on Day 5.
To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by
the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour
median pH after dose on Day 5
To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg
after repeated oral doses by the assessment of AUCĪ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and
t1/2,ss of esomeprazole after dose on Day 5.
To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg
by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse
rate and body temperature.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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