Relative Bioavailability of a Fentanyl Patch | NCT00857753

Studies
Relative Bioavailability of a Fentanyl Patch

NCT00857753

Sponsor

Sandoz

Status

Completed

Last Update Posted

Mar 29, 2017Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Pain

Interventions

Fentanyl patch 25 ug/nr Sandoz
Duragesic

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Oct 2006Actual

Completion Date

Oct 2006Actual

First Submitted Date

Mar 5, 2009

First Submission Date that Met QC Criteria

Mar 6, 2009

First Posted Date

Mar 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2017

Last Update Posted Date

Mar 29, 2017Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Fentanyl patch 25 ug/hr Sandoz	Drug: Fentanyl patch 25 ug/nr Sandoz
2	Active Comparator	Duragesic Patch 25 ug/hr	Drug: Duragesic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fentanyl patch 25 ug/nr Sandoz	Drug		1
Duragesic

Measure	Description	Time Frame
Bioequivalence according to US FDA guidelines		3 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Darin B. Brimhall, D.O.	Novum Pharmaceutical Research Services	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005283	Fentanyl

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided