A Relative Bioavailability Study of Rabeprazole Sodium Administered With Different Dosing Vehicles in Healthy Adult Volunteers

Phase 1 Completed 35 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedCrossoverOpen-label

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.

Timeline

Start: 2010-08
Primary completion: 2010-11
Completion: 2010-11

Outcome

Met primary endpoint

paper The 90%CIs for the least squares mean ratios for rabeprazole and rabeprazole thioether exposure were within the 80% to 125% bioequivalence limits PMID 22748970 ↗

Publications

Thyssen A, Solanki B, Treem W. Randomized, open-label, single-dose, crossover, relative bioavailability study in healthy adults, comparing the pharmacokinetics of rabeprazole granules administered using soft food or infant formula as dosing vehicle versus suspension. Clin Ther. 2012 Jul;34(7):1636-45. doi: 10.1016/j.clinthera.2012.06.008. Epub 2012 Jun 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rabeprazole	Small molecule	10 mg	Oral

Indications

No indication recorded.