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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 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02486016
The ClinicalTrials.gov registry entry for NCT02486016 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Duragesic reference fentanyl TDS is the first listed.
NCT02486016 reports 0 study locations.
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.
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