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NCT03100838 · ClinicalTrials.gov registry record · Phase 1
Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets
A Phase 1 study, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT03100838 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 64 participants.
The verdict
NCT03100838, a Phase 1 study, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study 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.
Interventions
- DRUG Nifedipine 60 MG Extended Release Oral Tablet
- DRUG omeprazole/sodium bicarbonate
- DEVICE SmartPill (TM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2017-03-20 |
| Est. Completion | 2018-04-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03100838
The ClinicalTrials.gov registry entry for NCT03100838 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Food and Drug Administration (FDA), which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nifedipine 60 MG Extended Release Oral Tablet is the first listed.
NCT03100838 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03100838 about?
NCT03100838 is a clinical study titled "Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets". 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...
What is the current status of trial NCT03100838?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2017-03-20. Estimated completion is 2018-04-06.
What interventions are being tested in trial NCT03100838?
The interventions under investigation include: Nifedipine 60 MG Extended Release Oral Tablet (DRUG), omeprazole/sodium bicarbonate (DRUG), SmartPill (TM) (DEVICE).
Who is sponsoring clinical trial NCT03100838?
This trial is sponsored by Food and Drug Administration (FDA), which has 23 total clinical trials registered on ClinicalTrials.gov.
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