drugset / Trial / NCT00747695
A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabreprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Years Old, Inclusive
Phase 1
Completed
31 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Eisai Inc. · collab
RandomizedSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to evaluate the pharmacokinetics, pharmacodynamics and safety of rabeprazole after single and multiple daily administration in children between the ages of 1 and 11 years, inclusive, with GERD.
Timeline
- Start
- 2008-03
- Primary completion
- —
- Completion
- 2009-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rabeprazole | Small molecule | 0.14 mg/kg | Oral |