A Bioequivalence Study of 2 Formulations of Rabeprazole Sodium and Evaluation of the Effect of Food on Rabeprazole Sodium in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2
      sprinkle capsule formulations of rabeprazole sodium when administered without food to healthy
      volunteers. In addition, the pharmacokinetics of 1 formulation of rabeprazole sodium will be
      evaluated when administered with food to healthy volunteers.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), open-label (the volunteer will know the
      treatment/drug they are taking), single-dose study of 2 formulations of rabeprazole sodium in
      healthy adult volunteers. Rabeprazole sodium is a drug used to treat patients with
      Gastroesophageal Reflux Disease (GERD), a condition where the esophagus (tube from throat to
      stomach) becomes irritated or inflamed as a result of acid that backs up into the esophagus
      from the stomach. All volunteers will receive 3 doses of study drug; each dose of study drug
      will be separated by at least 7 days. Blood samples will be collected from volunteers during
      the study to measure the concentration of study drug. Approximately 78 healthy volunteers
      will be enrolled and will participate in the study for a total of approximately 39 days.
      During the study, the healthy volunteer will make a total of approximately 4 visits to the
      study center. The 4 visits will include an initial screening visit and 3 visits to receive
      study drug. Volunteers will be required to stay at the study center for at least 12 hours
      before study drug administration and up to approximately 24 hours after study drug
      administration to have study procedures performed and blood samples collected to measure the
      concentrations of rabeprazole and its thioether metabolite (a substance produced when
      rabeprazole is metabolized in the body) in the plasma (ie, the clear liquid portion of
      blood). Volunteers will be monitored for safety throughout the study. Healthy volunteers will
      receive a single dose of study drug in 3 treatment periods. In each treatment period, healthy
      volunteers will receive one 10 mg capsule of rabeprazole sodium or two 5 mg capsules of
      rabeprazole sodium. The contents of study drug capsules will be sprinkled on 1 tablespoon of
      applesauce and administered orally (by mouth) to healthy volunteers in the morning who have
      fasted (not eaten) overnight and to those who have eaten a standardized breakfast.
    

Intervention name(s): Rabeprazole sodium: Treatment A; Rabeprazole sodium: Treatment B; Rabeprazole sodium: Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One single oral dose of 10 mg (1 x 10-mg capsule) rabeprazole to be-marketed sprinkle capsule granule formulation administered in fasted state. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).; One single oral dose of 10 mg (2 x 5-mg capsules) rabeprazole Phase 3 sprinkle capsule granule formulation administered in fasted state. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).; One single oral dose of 10 mg (1 x 10-mg capsule) rabeprazole to be-marketed sprinkle capsule granule formulation administered after consumption of a standardized high-fat high-caloric breakfast. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy; Sprinkle Capsule Formulation; Rabeprazole sodium; Pharmacokinetics; Bioequivalence; Safety