Conditions: Healthy
Keywords: Rabeprazole proton pump inhibitor pharmacokinetics pharmacodynamics healthy adult male Japanese subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover study.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Rabeprazole sodium, 5 mg Tablets intervention 2: Rabeprazole sodium, 10 mg Tablets intervention 3: Rabeprazole sodium, 20 mg Tablets intervention 4: Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)
Intervention descriptions: intervention 1: Rabeprazole sodium Tablets, 5 mg administered for 5 days.

Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.

Day 2 to Day 4: participants received a single dose with 200 mL of water \>= 2 hours after the completion of breakfast. intervention 2: Rabeprazole sodium Tablets, 10 mg administered for 5 days.

Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.

Day 2 to Day 4: participants received a single dose with 200 mL of water \>= 2 hours after the completion of breakfast. intervention 3: Rabeprazole sodium Tablets, 20 mg administered for 5 days.

Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.

Day 2 to Day 4: participants received a single dose with 200 mL of water \>= 2 hours after the completion of breakfast. intervention 4: Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) administered for 5 days.

Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.

Day 2 to Day 4: participants received a single dose with 200 mL of water, \>=2 hours after the completion of breakfast.

Protocol document: