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NCT00647842 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT00647842: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00647842 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00647842, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 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
- DRUG Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2005-11 |
| Est. Completion | 2006-02 |
| Phase | Phase 1 |
What the finished NCT00647842 record still lists
NCT00647842 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).
The record links to 0 conditions, and to 2 interventions - of which Fentanyl Transdermal System 25 mcg/h is the first listed.
NCT00647842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00647842 about?
NCT00647842 is a clinical study titled "Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System". 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 NCT00647842?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2005-11. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00647842?
The interventions under investigation include: Fentanyl Transdermal System 25 mcg/h (DRUG), Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay (DRUG).
Who is sponsoring clinical trial NCT00647842?
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 NCT00647842's enrollment target sits among peer trials
120 479th of 2000 higher than 1,503 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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