Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 120 participants
Start Date 2005-11
Est. Completion 2006-02
Phase Phase 1
Mylan Pharmaceuticals

146 total trials

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.

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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01174108 · 120 participants · Phase 2

    Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells

  • NCT01627301 · 120 participants · NA

    Sympathetic Overactivity in Post-traumatic Stress Disorder

  • NCT02025023 · 120 participants · Phase 3

    Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study

  • NCT02128906 · 120 participants · Phase 2

    Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00647842, the US trial registry maintained by the National Library of Medicine. NCT00647842 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.