NCT04397445View on ClinicalTrials.gov

Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

June 8, 2020

Primary Completion Date

July 1, 2020

Study Completion Date

July 1, 2020

Conditions
Ranitidine Adverse ReactionPharmacokineticsFood-drug Interaction
Interventions
DRUG

Ranitidine

Ranitidine 300 mg

DRUG

Placebo

Oral placebo tablet

OTHER

Low nitrite/NDMA meals

Meals containing low levels of nitrites and NDMA

OTHER

High nitrite/NDMA meals

Meals containing higher levels of nitrites and NDMA

Trial Locations (1)

53095

Spaulding Clinical Research, West Bend

All Listed Sponsors
collaborator

Spaulding Clinical Research LLC

OTHER

lead

Food and Drug Administration (FDA)

FED

NCT04397445 - Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration | Biotech Hunter | Biotech Hunter