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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 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 120 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00647842
The ClinicalTrials.gov registry entry for NCT00647842 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fentanyl Transdermal System 25 mcg/h is the first listed.
NCT00647842 reports 0 study locations.
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.
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