A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2
      different formulations, assess the effect of food on the pharmacokinetics and assess safety
      of rabeprazole sodium in healthy 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 a randomized (study drug assigned by chance), open-label (the patient knows the
      treatment/drug they are taking), single-dose, 3-way crossover study to evaluate and compare
      the pharmacokinetics (blood levels) and safety of 2 formulations of orally (by mouth)
      administered rabeprazole sodium in healthy volunteers. Rabeprazole sodium is a drug used to
      treat patients with Gastro Esophageal Reflux Disease (GERD), a condition in which the
      esophagus (tube from throat to stomach) becomes irritated or inflamed because of acid backing
      up from the stomach. The primary outcome measure of the study is to evaluate the relative
      bioavailability (the rate and extent at which the drug is absorbed and reaches blood
      circulation ) of rabeprazole sodium (Phase 3 versus Phase 1 formulation) and the effect of
      food (Phase 3 formulation) by estimation of standard plasma PK parameters (Cmax, the maximum
      concentration of the drug in the blood observed after its administration; tmax, the time it
      takes for the drug to reach its maximum concentration in the blood after its administration;
      and AUC [the area under the curve]) of rabeprazole and its major metabolite.Blood samples to
      assess the PK of study drugs will be obtained before and up to 16 hours after dosing on Day 1
      during 3 treatment periods. Thirty-six (36) healthy volunteers will be enrolled and will
      participate in the study for a total of approximately 36 days (from beginning of screening
      until the end-of-study procedures). During the study, the healthy volunteer will make a total
      of approximately 4 visits to the study center. The 4 visits will include a screening visit
      and three 2-day inpatient stays to receive study drug. During the screening visit, the
      details regarding the study will be explained and if the volunteer wishes to participate in
      the study, a signed informed consent form will be obtained. After informed consent is
      obtained, study specific entry criteria will be reviewed with the volunteer, information
      regarding the volunteer's medical history and demographics (age, race, etc) will be
      collected, and the following procedures will be performed: physical examination, measurement
      of vital signs (pulse rate and blood pressure), 12-lead electrocardiogram (ECG), serum
      pregnancy test (for women of childbearing potential), serology, drug screen and alcohol test,
      and laboratory testing (hematology, serum chemistry, and urinalysis). During each treatment
      period, volunteers who fulfill study enty criteria will be randomized to receive 1 of 3
      treatments as follows: (1) a strawberry flavored suspension of the phase 1 formulation of
      study drug in a fasted state (2) a strawberry flavored suspension of the phase 3 formulation
      of study drug in a fasted state , and (3) a strawberry flavored suspension of the phase 3
      formulation of study drug in a fed state (with food) OR phase 3 formulation of study drug
      sprinkled on 1 ounce of plain yogurt. During each 2-day treatment period, volunteers will be
      admitted to the study center after an overnight fasting (withholding consumption of food)
      period of at least 8 hours before blood is drawn for laboratory safety testing on Day 1,
      receive study drug on Day 1, and remain overnight at the study center unit for completion of
      all Day 2 study procedures. After all Day 2 study procedures are completed, the volunteer
      will be discharged from the study center unit for a 7- to 14-day period and then return to
      the study center for the 2nd treatment period. The same procedures will be followed for
      treatment periods 2 and 3. During the study, safety will be monitored by the measurement of
      vital signs before and after dosing during each treatment period, ECG findings at screening
      and at the end-of-study (Day 2 of treatment period 3 or at the time of early withdrawal from
      the study), and the evaluation of adverse events reported from the time of screening through
      to the end of the study. In each of 3 treatment periods, healthy volunteers will receive the
      equivalent of a 10 mg dose of rabeprazole sodium (ie, four 2.5 mg capsules of the phase 3
      pediatric bead formulation or two 5-mg sachets of the phase 1 pediatric bead formulation)
      mixed with a strawberry-flavored vehicle and administered orally as a suspension or they will
      receive four 2.5 mg capsules of the phase 3 formulation sprinkled on plain yogurt to be
      ingested (eaten).
    

Intervention name(s): rabeprazole sodium; rabeprazole sodium; rabeprazole sodium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): four 2.5 mg capsules of the phase 3 pediatric bead formulation suspended in a strawberry flavored vehicle (taken in fasted or fed state); two 5-mg sachets of the phase 1 pediatric bead formulation suspended in a strawberry flavored vehicle (taken in fasted state); four 2.5 mg capsules of the phase 3 formulation sprinkled on 1 ounce of plain yogurt
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Rabeprazole sodium; Pharmacokinetics; Biological Availability; Safety; Adult