BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects

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.

Timeline

Start

2013-10

Primary completion

2013-12

Completion

2013-12

Drugs

Indications