Trials / Completed
CompletedNCT00687245
Pharmacokinetic Study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 1 Year – 11 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the area under the plasma concentration-time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg or 20 mg esomeprazole in pediatric patients 1 to 11 years-old inclusive with endoscopically-proven GERD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | esomeprazole magnesium | capsules, oral, qd, one day |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2008-05-01
- Completion
- 2008-05-01
- First posted
- 2008-05-30
- Last updated
- 2008-06-11
Source: ClinicalTrials.gov record NCT00687245. Inclusion in this directory is not an endorsement.