Relative Bioavailability of a Fentanyl Patch

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00857753

Enrollment

Registered

2009-03-09

Start date

2006-09-30

Completion date

2006-10-31

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

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

Interventions

DRUGFentanyl patch 25 ug/nr Sandoz

DRUGDuragesic

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bioequivalence according to US FDA guidelines	3 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026