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NCT02531971 · ClinicalTrials.gov registry record · Phase 4
Fentanyl Patch Pharmacokinetics in Healthy Adults
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT02531971: Completed Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT02531971 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02531971, a Phase 4 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery comparisons between RLD (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and Generic Fentanyl TDDS in healthy adults and to ensure safety of individuals utilizing these types of products.
Primary Outcome
drug concentration in serum vs. time; reflects the actual body exposure to drug after administration of a dose of the drug
Interventions
- DRUG Intravenous fentanyl citrate
- DRUG Duragesic®
- DRUG Mylan generic fentanyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-01-14 |
| Est. Completion | 2018-10-16 |
| Phase | Phase 4 |
What the finished NCT02531971 record still lists
NCT02531971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Intravenous fentanyl citrate is the first listed.
NCT02531971 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02531971 about?
NCT02531971 is a clinical study titled "Fentanyl Patch Pharmacokinetics in Healthy Adults". The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery comparisons between RLD (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and Generic Fentanyl TDDS in hea...
What is the current status of trial NCT02531971?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2016-01-14. Estimated completion is 2018-10-16.
What interventions are being tested in trial NCT02531971?
The interventions under investigation include: Intravenous fentanyl citrate (DRUG), Duragesic® (DRUG), Mylan generic fentanyl (DRUG).
Who is sponsoring clinical trial NCT02531971?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02531971's enrollment target sits among peer trials
24 1699th of 2000 higher than 276 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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