BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
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.