drugset
drugset / Trial / NCT03100838

Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets

NCT03100838 ↗

Phase 1 Completed 64 enrolled Food and Drug Administration (FDA) BioPharma Services Inc. · collab
RandomizedCrossoverOpen-labelOther

Summary

The purpose of this study is to measure the amount of study drug present in blood after being administered a generic version of nifedipine extended-release tablets, 60 mg (Valeant Pharmaceuticals, LLC) and brand-name version PROCARDIA XL extended-release tablets, 60 mg (Pfizer Inc.) individually and in presence of stomach acid reducing drug (antacid), omeprazole/sodium bicarbonate capsules, 40 mg/1100 mg (generic) on separate occasions, on an empty stomach. This study also involves administrations of an FDA-cleared capsule, SmartPill™, which will measure stomach acid, prior to each study arm.

Timeline

Start
2017-03-20
Primary completion
2017-12-23
Completion
2018-04-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Nifedipine Other / unclassified 60 mg Oral
Comparator Omeprazole Other / unclassified 40 mg Oral
Comparator sodium bicarbonate Diagnostic / imaging agent 1100 mg Oral

Indications

No indication recorded.