A Phase 1 interventional study of Rabeprazole sodium: Treatment A and Rabeprazole sodium: Treatment B in Healthy, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-30.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 1 and Interventional
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.
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.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
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Drug: Rabeprazole sodium: Treatment A · Drug: Rabeprazole sodium: Treatment B · Drug: Rabeprazole sodium: Treatment C
Drug: Rabeprazole sodium: Treatment A · Drug: Rabeprazole sodium: Treatment B · Drug: Rabeprazole sodium: Treatment C
Drug: Rabeprazole sodium: Treatment A · Drug: Rabeprazole sodium: Treatment B · Drug: Rabeprazole sodium: Treatment C
Drug: Rabeprazole sodium: Treatment A · Drug: Rabeprazole sodium: Treatment B · Drug: Rabeprazole sodium: Treatment C
Drug: Rabeprazole sodium: Treatment A · Drug: Rabeprazole sodium: Treatment B · Drug: Rabeprazole sodium: Treatment C
Drug: Rabeprazole sodium: Treatment A · Drug: Rabeprazole sodium: Treatment B · Drug: Rabeprazole sodium: Treatment C
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).
Plasma concentrations of rabeprazole sodium
Time frame: Up to 16 hours after each study drug administration
Plasma concentrations of thioether metabolite
Time frame: Up to 16 hours after each study drug administration
The number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to approximately 39 days
No study locations are listed for this record.
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.