Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males

Open Label, Randomized, Single Center, 2-way Crossover Bioequivalence Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule 40 mg D961H After Repeated Oral Administration in Japanese Healthy Male Subjects

The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5

Inclusion Criteria:

• Healthy Japanese
• Classified as homo-EM
• Negative for HIV, Hepatitis B, Hepatitis C and syphilis

Exclusion Criteria:

• Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
• Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease