Relative Bioavailability of Rabeprazole Sodium Sprinkle Capsule Formulation Using Different Dosing Vehicles Following Single-dose Administration in Healthy Adult Subjects

This is an open-label (volunteer and investigator will know the name of the assigned treatment) single center study to evaluate the bioavailability (rate and extent of absorption) and safety of different dosing vehicles used to administer a pediatric formulation of rabeprazole sodium to healthy adult volunteers. A dosing vehicle is a food or liquid that is mixed with rabeprazole sodium for oral (by mouth) administration. Approximately 35 healthy adult volunteers will be enrolled and randomized (assigned by chance) to 1 of 5 possible treatment sequences to receive each of the following single-dose treatments: 1) the contents of rabeprazole sprinkle capsules mixed in a strawberry-flavored vehicle suspension (Treatment A), 2) the contents of rabeprazole sprinkle capsules sprinkled on 1 tablespoon of plain yogurt (Treatment B), 3) the contents of rabeprazole sprinkle capsules sprinkled on 1 tablespoon of applesauce (Treatment C), 4) the contents of rabeprazole sprinkle capsules mixed with 5 mL (1 teaspoon) of formula milk (Treatment D), and 5) the contents of rabeprazole sprinkle capsules mixed in a tablet vehicle suspension (Treatment E). Each volunteer will receive 5 single-dose treatments during the study (1 single-dose treatment during each treatment period). A period of at least 7 days will separate each treatment period. During each treatment period, volunteers will be required to stay overnight at the study center for 12 hours before study drug administration up to approximately 24 hours after study drug administration to have study procedures performed and blood samples collected to measure the concentration of rabeprazole and its thioether metabolite (a substance produced when rabeprazole is absorbed in the body). Volunteers will fast (withhold from eating food) for at least 10 hours before study drug administration and up to at least 4 hours after study drug administration. On dosing days, volunteers will not receive a morning meal but will be allowed to drink non-carbonated water for up to 2 hours before study drug administration. After dosing, a standard lunch, snack, and dinner will be provided to volunteers. Each volunteer will participate in the study for approximately 55 days and be monitored for safety during the study by evaluating adverse events reported and results from clinical laboratory tests, 12-lead electrocardiograms (ECGs), vital sign measurements, and physical examinations. On Day 1 of each treatment period, volunteers will be administered the contents from 2 capsules equivalent to 10 mg of rabeprazole sodium mixed with a strawberry-flavored vehicle reconstituted with water or a vehicle tablet reconstituted with water (Treatments A and E, respectively) or 10 mg rabeprazole sodium sprinkled on 1 tablespoon of plain yogurt or applesauce (Treatments B and C, respectively), or 10 mg rabeprazole sodium mixed with 5 mL of formula milk (Treatment D).