Relative Bioavailability of a Fentanyl Patch

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Fentanyl patch 25 ug/nr Sandoz

Drug

Duragesic

Drug

Primary outcomes

Bioequivalence according to US FDA guidelines

Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

A Study to Evaluate the Relative Bioavailability of a Fentanyl PAtch Transdermal Delivery System (25 ug/hr) (Sandoz) Compared to Duragesic (Fentanyl Transdermal SYstem 25 ug/hr Patches (Alza)

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Mar 9, 2009
Registry last updated: Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed