Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System
Public ClinicalTrials.gov record NCT00647842. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Single-Dose In Vivo Bioequivalence and Wear Study of Fentanyl Transdermal System (25 µg/h; Mylan) and Fentanyl Transdermal System With Overlay (25 µg/h; Mylan) in Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00647842
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Interventions
- Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay Drug
- Fentanyl Transdermal System 25 mcg/h Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2005 (Type not available)
- Primary completion
- Feb 2006 (Actual)
- Completion
- Feb 2006 (Actual)
- Last update posted
- Apr 23, 2024
2005 – 2006
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kendle International Inc. | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00647842, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00647842 live on ClinicalTrials.gov.