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Fentanyl System/h+ Askina Derm Overlay

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 23, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

Fentanyl System/h+ Askina Derm Overlay · 2 trials · 1 indication

Phase 1 2
NCT00647686Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System With Askina Derm OverlayHealthy
COMPLETED80 Analytics
NCT00647842Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal SystemHealthy
COMPLETED120 Analytics
PHASE1COMPLETED
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System With Askina Derm Overlay
Healthy
NCT0064768680
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PHASE1COMPLETED
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System
Healthy
NCT00647842120
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Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALFentanyl Transdermal System 25 mcg/h + Askina Derm Overlay
2ACTIVE_COMPARATORFentanyl Transdermal System 25 mcg/h

Interventions

NameTypeDescription
Fentanyl Transdermal System 25 mcg/h + Askina Derm OverlayDRUGsingle application
Fentanyl Transdermal System 25 mcg/hDRUGsingle application
Fentanyl Transdermal System 25 mcg/h + Bioclusive OverlayDRUGsingle application
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 21 days prior to the start of the study and on the ev...

Countries:United States
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