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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: Completed Phase 1 study, sponsored by Food and Drug Administration (FDA).
NCT03100838 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measurement of plasma nifedipine prior to dosing and at times 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24, 36 and 48 hr after nifedipine administration.
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 |
What the finished NCT03100838 record still lists
NCT03100838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Nifedipine 60 MG Extended Release Oral Tablet is the first listed.
NCT03100838 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03100838's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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