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NCT00650117 · 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
- 12
- Enrollment target
NCT00650117 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 12 participants.
The verdict
NCT00650117, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation. The acute irritation of each type of overlay worn with each fentanyl treatment was also assessed after patch removal.
Interventions
- DRUG Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M)
- DRUG Duragesic 25 mcg/h + Scotch Duct Tape (3M)
- DRUG Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
- DRUG Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M)
- DRUG Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2006-10 |
| Est. Completion | 2006-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00650117
The ClinicalTrials.gov registry entry for NCT00650117 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 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 5 interventions - of which Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M) is the first listed.
NCT00650117 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00650117 about?
NCT00650117 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 to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceuti...
What is the current status of trial NCT00650117?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2006-10. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00650117?
The interventions under investigation include: Mylan Fentanyl Transdermal System 25 mcg/h + Scotch Duct Tape (3M) (DRUG), Duragesic 25 mcg/h + Scotch Duct Tape (3M) (DRUG), Mylan Fentanyl Transdermal System 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M) (DRUG), Duragesic 25 mcg/h + Blenderm Clear Plastic Surgical Tape (3M) (DRUG), Mylan Fentanyl Transdermal System 25 mcg/h + Microfoam Tape (3M) (DRUG).
Who is sponsoring clinical trial NCT00650117?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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