Study identifier:D9614C00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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)
endoscopically-proven GERD
Phase 1
No
esomeprazole magnesium
All
40
Interventional
1 Years - 11 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Other
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 esomeprazole magnesium 5 mg, weight 8 kg to < 20kg | Drug: esomeprazole magnesium capsules, oral, qd, one day Other Name: Nexium |
Experimental: 2 esomeprazole magnesium 10 mg, weight 8 kg to < 20kg | Drug: esomeprazole magnesium capsules, oral, qd, one day Other Name: Nexium |
Experimental: 3 esomeprazole magnesium 10 mg, weight > 20 kg | Drug: esomeprazole magnesium capsules, oral, qd, one day Other Name: Nexium |
Experimental: 4 esomeprazole magnesium 20 mg, weight > 20 kg | Drug: esomeprazole magnesium capsules, oral, qd, one day Other Name: Nexium |
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