A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet (Study E5501-J081-015)

"The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days.~Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.~The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively."

"The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): one 5 mg tablet under fed conditions on treatment morning for 28 days.~Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.~The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively."

"The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days.~Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.~The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively."