Overview

Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets

Status:
Completed

Trial end date:
2018-04-06

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Food and Drug Administration (FDA)

Collaborator:

BioPharma Services, Inc

Treatments:

Nifedipine
Omeprazole
Proton Pump Inhibitors