Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration
Phase: PHASE1
Conditions: Ranitidine Adverse Reaction, Pharmacokinetics, Food-drug Interaction
Sponsor: Food and Drug Administration (FDA)

Study Title: Clinical Study to Investigate the Urinary Excretion of N-
nitrosodimethylamine (NDMA) after Ranitidine Administration   
 
Document Title: Clinical Study Protocol No. SCR-010  
 
Document Date : 19 June 2020 
 
NCT Number: NCT04397445 

Digitally signed by David Strauss -S 
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 
cn=David Strauss -S, 0.9.2342.19200300.100.1.1=2000507494 
Date: 2020.06.22 15:00:21 -04'00'