HealthyPhase 1NCT00864565
A Relative Bioavailability Study of Fentanyl 25 μg/h Transdermal System
A Phase 1 study testing Fentanyl 25 μg/h transdermal system, single application and Duragesic 25 μg/h transdermal system single application in people with Healthy, run by Actavis Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fentanyl 25 μg/h transdermal system, single application and Duragesic 25 μg/h transdermal system single application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2003to Jun 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be females and/or males, smokers and/or non-smokers, between 18 and 55 years of age.
- Subject capable of consent.
- 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.
Who cannot join
- 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.
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- 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.
- History or presence of any clinically significant liver or kidney disease or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug.
- Any history or presence of clinically significant neurological. endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Smoking more than 25 cigarettes per day.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subject's participation in this study.
- Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows:
- 1.less than 300 mL of whole blood within 30 days or 2.300 mL to 500 mL of whole blood within 45 days or 3.more than 500 mL of whole blood within 56 days .
- Subjects who have consumed food or beverages containing grapefruit (e.g. fresh, canned, or frozen) within 7 days prior to administration of the study medication.
- Subjects with a history or presence of asthma. chronic obstructive pulmonary disease or other pulmonary condition that may predispose to hypoventilation.
- Subjects with a history or presence of bradyarrythmias.
- Additional criteria for females only:
- Breast-feeding subjects.
- Positive urine pregnancy test at screening (performed on all females).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, 2-way Crossover, Bioequivalence Study of Fentanyl 25 μg/h Transdermal System and Duragesic 25 μg/h Transdermal System Administrated as 1 x 25 μg/h Single Application in the Healthy Subjects
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.
Read the detailed description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Randomized, 2-way crossover, bioequivalence study of Fentanyl 25 μg/h transdermal system and Duragesic 25 μg/h transdermal system administrated as 1 x 25 μg/h single application in the healthy subjects
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
- Conditions
- Healthy
- Being tested
- Fentanyl 25 μg/h transdermal system, single application, Duragesic 25 μg/h transdermal system single application
- Keywords
- Bioequivalence, Fentanyl, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl 25 μg/h transdermal system, single applicationDrug
Also called Fentanyl
A: Experimental Subjects received Corium International, Inc formulated products
Duragesic 25 μg/h transdermal system single applicationDrug
Also called Fentanyl
B: Active comparator Subjects received Jassen Pharmaceutica Products, L.P. formulated products
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Fentanyl 25 μg/h transdermal system, single application Receives: Drug: Fentanyl 25 μg/h transdermal system, single application |
| B | Active comparator | Duragesic 25 μg/h transdermal system single application Receives: Drug: Duragesic 25 μg/h transdermal system single application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 132 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startJun 2003
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Benoit Girard, Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864565
- Sponsor's protocol ID
- 02348
- Status last verified
- Aug 2010
- First submitted
- 17 Mar 2009
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 2-way Crossover, Bioequivalence Study of Fentanyl 25 μg/h Transdermal System and Duragesic 25 μg/h Transdermal System Administrated as 1 x 25 μg/h Single Application in the Healthy Subjects
- ClinicalTrials.gov ID
- NCT00864565
- Acronym / sponsor ID
- 02348
- Conditions
- Healthy
- Keywords
- Bioequivalence, Fentanyl, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Randomized, 2-way crossover, bioequivalence study of Fentanyl 25 μg/h transdermal system and Duragesic 25 μg/h transdermal system administrated as 1 x 25 μg/h single application in the healthy subjects
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Fentanyl 25 μg/h transdermal system, single applicationFentanyl 25 μg/h transdermal system, single application |
| B | Active comparator | Drug: Duragesic 25 μg/h transdermal system single applicationDuragesic 25 μg/h transdermal system single application |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects will be females and/or males, smokers and/or non-smokers, between 18 and 55 years of age.
- Subject capable of consent.
- Female subjects will be post-menopausal or surgically sterilized.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl 25 μg/h transdermal system, single applicationAlso: FentanylA: Experimental Subjects received Corium International, Inc formulated products | Drug | A |
| Duragesic 25 μg/h transdermal system single applicationAlso: FentanylB: Active comparator Subjects received Jassen Pharmaceutica Products, L.P. formulated products | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 132 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Girard principal investigator
Anapharm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fentanyl 25 μg/h transdermal system, single application and Duragesic 25 μg/h transdermal system single application in people with Healthy, run by Actavis Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate and Extend of Absorption (time frame: 132 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2010.