NCT00857753

Brief Summary

Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch transdermal delivery system.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 pain

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_1 pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2009

Enrollment Period

1 month

First QC Date

March 5, 2009

Last Update Submit

March 27, 2017

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence according to US FDA guidelines

    3 weeks

Study Arms (2)

1

EXPERIMENTAL

Fentanyl patch 25 ug/hr Sandoz

Drug: Fentanyl patch 25 ug/nr Sandoz

2

ACTIVE COMPARATOR

Duragesic Patch 25 ug/hr

Drug: Duragesic

Interventions

Fentanyl patch 25 ug/nr SandozDRUG
1
DuragesicDRUG
2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal findings on physical exam, medical history or clinical laboratory tests on screening.

You may not qualify if:

  • Negative test for HIV and hepatitis B and C
  • No history of drug or alcohol treatment
  • No allergies to opiates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Darin B. Brimhall, D.O.

    Novum Pharmaceutical Research Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 9, 2009

Study Start

September 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

March 29, 2017

Record last verified: 2009-03