ACIPHEX SPRINKLE

Peak

rabeprazole sodium

NDAORALCAPSULE, DELAYED RELEASEPriority Review
Approved
Mar 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
7

Mechanism of Action

(substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H 2 -receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H , K ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded…

Clinical Trials (5)

NCT01241409Phase 1Completed

A Bioequivalence Study of 2 Formulations of Rabeprazole Sodium and Evaluation of the Effect of Food on Rabeprazole Sodium in Healthy Adult Volunteers

Started Oct 2010
78 enrolled
Healthy
NCT01202071Phase 2Completed

A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)

Started Sep 2010
24 enrolled
Healthy
NCT01186497Phase 1Completed

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

Started Aug 2010
35 enrolled
Healthy
NCT01101646Phase 1Completed

A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers

Started Aug 2008
36 enrolled
Gastroesophageal Reflux
NCT00464308Phase 4Completed

A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg

Started Nov 2006
1,392 enrolled
Gastro-oesophageal Reflux