NCT00864565

CompletedPhase 1

A Relative Bioavailability Study of Fentanyl 25 μg/h Transde...

Actavis Inc.Source

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Other study identifiers

Sponsor study identifier

02348

Study Type

interventional

Actual enrollment (reported)

48

Locations

1 country

Sites

1

Timeline

Study Start

June 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2003

Actual (reported)

Study Completion

June 2003

Actual (reported)

Brief Summary

To compare the rate and extent of absorption of fentanyl 25 μg/h transdermal system (test) and Duragesic (reference) administrated as 1 x 25 μg/h single transdermal system application.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 48 participants
Study completion date: June 2003
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2003
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 2003
Actual (reported)
Study Completion
June 2003
Actual (reported)
First Submitted
March 17, 2009
Actual (reported)
First Posted
March 18, 2009
Actual (reported)

Last Updated: August 16, 2010
Status Verified: August 2010
Last Update Submitted: August 13, 2010

Conditions

Healthy

Keywords

BioequivalenceFentanylHealthy subjects

Outcome Measures

Primary Outcomes (1)

Rate and Extend of Absorption
132 hours

Study Arms (2)

A

EXPERIMENTAL

Fentanyl 25 μg/h transdermal system, single application

Drug: Fentanyl 25 μg/h transdermal system, single application

B

ACTIVE COMPARATOR

Duragesic 25 μg/h transdermal system single application

Drug: Duragesic 25 μg/h transdermal system single application

Interventions

Fentanyl 25 μg/h transdermal system, single applicationDrug

A: Experimental Subjects received Corium International, Inc formulated products

Also known as: Fentanyl

A

Duragesic 25 μg/h transdermal system single applicationDrug

B: Active comparator Subjects received Jassen Pharmaceutica Products, L.P. formulated products

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Subjects will be females and/or males, smokers and/or non-smokers, between 18 and 55 years of age.
Subject capable of consent.

Sponsors & Collaborators

Actavis Inc.
Industrylead

Study Sites (1)

Anapharm Inc

Québec, Quebec, G1V2K8, Canada

MeSH Terms

Interventions

FentanylTransdermal Patch

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEquipment and Supplies

Study Officials

Benoit Girard
Anapharm
PRINCIPAL INVESTIGATOR

Enrollment

48 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

June 2003

Date type not reported

This date has not been verified as actual or estimated.

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Phase 1Completed

NCT00864435

A Relative Bioavailability Study of Carvedilol 12.5 mg Tablets Under Fasting Conditions

Phase 1Completed

Also known as: Fentanyl

B

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Female subjects will be post-menopausal or surgically sterilized.

Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at least 6 months ago.

Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.

You may not qualify if:

Clinically significant illnesses within 4 weeks of the administration of study medication.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Any clinically significant abnormality found during medical screening.
Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
Abnormal laboratory tests judged clinically significant.
Positive urine drug screen at screening.
Positive testing for hepatitis B, hepatitis C or HlV at screening.
ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, or diastolic blood pressure lower than 60 or over 90 mmHg; or heart rate less than 60 or over 100 bpm) at screening.
Subjects with BMI \>30.0.
History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (1 Unit ≈ 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
History of abuse or dependency or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within I year of the screening visit.
History of allergic reactions to fentanyl, naloxone or adhesives.
History of allergic reactions to heparin.
Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO .inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration -of the study medication.
Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
+14 more criteria

Contact the study team to confirm eligibility.

Primary Completion

June 2003

Actual (reported)

Study Completion

June 2003

Actual (reported)

Last Updated

August 16, 2010

Record last verified: 2010-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00864565
Data provider: ClinicalTrials.gov
Source updated: 2010-08-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:34 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations