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NCT02486016 · ClinicalTrials.gov registry record · Phase 4
Transdermal Patch CVD 2000: The Effect of Heat on Fentanyl Release From Fentanyl TDSs in Healthy Adults
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT02486016: Completed Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT02486016 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02486016, a Phase 4 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan) fentanyl (transdermal delivery system)TDSs in healthy adults.
Primary Outcome
Partial area under the flux-time curve of fentanyl calculated from 11 to 14 h for Early Heat and 18 to 21 h for Late Heat study designs Blood samples obtained at 15 min prior to patch application \[baseline\], and at 1:00, 10:00, 10:55, 11:05, 11:15, 11:25, 11:35, 11:45, 12:00, 13:00, 14:00, 16:00, 17:00, 17:55, 18:05, 18:15, 18:25, 18:35, 18:45, 19:00, 20:00, 21:00, and 22:00 h post-patch application
Interventions
- DRUG Duragesic reference fentanyl TDS
- DRUG Apotex generic fentanyl TDS
- DRUG Mylan generic fentanyl TDS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-07-09 |
| Est. Completion | 2017-08-09 |
| Phase | Phase 4 |
What the finished NCT02486016 record still lists
NCT02486016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Duragesic reference fentanyl TDS is the first listed.
NCT02486016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02486016 about?
NCT02486016 is a clinical study titled "Transdermal Patch CVD 2000: The Effect of Heat on Fentanyl Release From Fentanyl TDSs in Healthy Adults". This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan) fentanyl (transdermal delivery system)TDSs in healthy adults.
What is the current status of trial NCT02486016?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2015-07-09. Estimated completion is 2017-08-09.
What interventions are being tested in trial NCT02486016?
The interventions under investigation include: Duragesic reference fentanyl TDS (DRUG), Apotex generic fentanyl TDS (DRUG), Mylan generic fentanyl TDS (DRUG).
Who is sponsoring clinical trial NCT02486016?
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 NCT02486016's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 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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