A Relative Bioavailability Study of Rabeprazole Sodium Administered With Different Dosing Vehicles in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the bioavailability (rate and extent of
      absorption) of rabeprazole sodium when a sprinkle capsule granule formulation of rabeprazole
      sodium is mixed with different dosing vehicles (food, others) and is administered to healthy
      adult volunteers. Rabeprazole sodium is a drug used to treat patients with Gastro Esophageal
      Reflux Disease (GERD). GERD is a condition in which the esophagus (tube from throat to
      stomach) becomes irritated or inflamed because of acid backing up from the stomach.
    

Detailed description: 
      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).
    

Intervention name(s): Rabeprazole sodium: Treatment E; Rabeprazole sodium: Treatment C; Rabeprazole sodium: Treatment D; Rabeprazole sodium: Treatment A; Rabeprazole sodium: Treatment B
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a tablet vehicle suspension (Treatment E) on Day 1.; The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of applesauce (Treatment C) on Day 1.; The contents of 2 rabeprazole sprinkle capsules containing 10 mg rabeprazole sodium mixed with 5 mL (1 teaspoon) of formula milk (Treatment D) on Day 1.; The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a strawberry-flavored vehicle suspension (Treatment A) on Day 1.; The contents of 2 rabeprazole sodium sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of plain yogurt (Treatment B) on Day 1.
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy; Rabeprazole sodium; Rabeprazole sprinkle capsule granule formulation; Pharmacokinetics; Bioavailability; Safety; Adult