NCT03100838View on ClinicalTrials.gov

Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

March 20, 2017

Primary Completion Date

December 23, 2017

Study Completion Date

April 6, 2018

Conditions
Healthy Volunteers
Interventions
DRUG

Nifedipine 60 MG Extended Release Oral Tablet

Reference Drug (Brand)

DRUG

Nifedipine 60 MG Extended Release Oral Tablet

Test Drug (Generic)

DRUG

omeprazole/sodium bicarbonate

Proton Pump Inhibitor/Antacid for drug-drug interaction

DEVICE

SmartPill (TM)

Gastric pH measurement using SmartPill (TM) Technology

Trial Locations (1)

65201

BioPharma Services Inc., Columbia

Sponsors

Collaborators (1)

BioPharma Services Inc.
All Listed Sponsors
collaborator

BioPharma Services Inc.

INDUSTRY

lead

Food and Drug Administration (FDA)

FED