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Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets

NCT03100838 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-08-16

Study results available
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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.

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

Sponsors & Collaborators

  • BioPharma Services Inc.

    collaborator INDUSTRY

  • Food and Drug Administration (FDA)

    lead FED

Principal Investigators

  • Kathleen Doisy · BioPharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2017-12-23
Completion
2018-04-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03100838 on ClinicalTrials.gov