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Urinary Excretion of NDMA After Ranitidine
NCT04397445Phase 1Completed
- Sponsor
- Food and Drug Administration
- Start
- Jun 2020
- Primary completion
- Jul 2020
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of ranitidine in gastroesophageal reflux disease (GERD), gastric ulcer and duodenal ulcer (4 arms), sponsored by Food and Drug Administration. Primary endpoint: Cumulative NDMA Amount Excreted in Urine Over 24 Hours After Drug Administration (Comparison Between Ranitidine and Placebo). Started Jun 2020; status: completed.
02
Drugs
ranitidine
03
Conditions
gastroesophageal reflux disease (GERD)gastric ulcerduodenal ulcer
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