Relative Bioavailability of a Fentanyl Patch

Sandoz

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Fentanyl patch 25 ug/nr Sandoz; Drug: Duragesic

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857753

10613401

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Experimental group

Description:

Fentanyl patch 25 ug/hr Sandoz

Treatment:

Drug: Fentanyl patch 25 ug/nr Sandoz

2

Active Comparator group

Description:

Duragesic Patch 25 ug/hr

Treatment:

Drug: Duragesic