NCT00857753CompletedPhase 1
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sandoz
- Enrollment
- 40
- Primary Endpoint
- Bioequivalence according to US FDA guidelines
Study Overview
Brief Summary
Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch transdermal delivery system.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1
Experimental
Fentanyl patch 25 ug/hr Sandoz
Intervention: Fentanyl patch 25 ug/nr Sandoz (Drug)
2
Active Comparator
Duragesic Patch 25 ug/hr
Intervention: Duragesic (Drug)
Outcomes
Primary Outcomes
Bioequivalence according to US FDA guidelines
Time Frame: 3 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
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