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NCT00647686 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System With Askina Derm Overlay
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT00647686: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00647686 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00647686, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
The objective of this study was primarily to investigate the bioequivalence and secondly to assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system with and without an overlay system following a single 25 µg/hr application worn for 72 hours.
Interventions
- DRUG Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay
- DRUG Fentanyl Transdermal System 25 mcg/h
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2006-06 |
| Est. Completion | 2006-07 |
| Phase | Phase 1 |
What the finished NCT00647686 record still lists
NCT00647686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay is the first listed.
NCT00647686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00647686 about?
NCT00647686 is a clinical study titled "Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System With Askina Derm Overlay". The objective of this study was primarily to investigate the bioequivalence and secondly to assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system with and without an overlay system following a single 25 µg/hr application worn for 72 hours.
What is the current status of trial NCT00647686?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2006-06. Estimated completion is 2006-07.
What interventions are being tested in trial NCT00647686?
The interventions under investigation include: Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay (DRUG), Fentanyl Transdermal System 25 mcg/h (DRUG).
Who is sponsoring clinical trial NCT00647686?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00647686's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 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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