BioequivalenceEarly Phase 1NCT01592019
Clinical Study to Evaluate the Role of Microdialysis for the Comparison of Topical Products
A Early Phase 1 study testing Reference, Patch location thigh, batch 1, Test, Patch location thigh, batch 2 and Reference, Patch location abdomen, batch 1 in people with Bioequivalence, run by University of Florida at 1 site in United States.
Trial summary
The investigators hypothesize that a technique called microdialysis can be used to measure the amount of the drug diclofenac which penetrates (enters) the fatty tissue under the skin. Microdialysis uses a small device called a 'probe' to determine the amount of drug which enters a body tissue. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Reference, Patch location thigh, batch 1, Test, Patch location thigh, batch 2 and Reference, Patch location abdomen, batch 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Nov 2012
- Phase
- Early 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
- Males or females, between 18 and 55 years of age.
- Body mass index of 18.5 and 32 kg/m2, inclusive.
- Non-smoker (not smoked for 12 months prior to screening).
- Healthy on the basis of physical examination, medical history, and vital signs.
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel (including liver enzymes, other specific tests) and hematology are outside the normal reference ranges, the subject may be included only if the study physician judges the abnormalities or deviations from normal to be not clinically significant.
- Female subjects must be postmenopausal (for at least 6 months), surgically sterile, or abstinent; or, if of childbearing potential and sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) before entry and throughout the study. Also, subjects must have a negative serum human chorionic gonadotropin pregnancy test at the initial screening.
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- Agree not to consume any alcohol 72 hours prior to application of the study patch and until discharge from the unit.
- Agree not to use diclofenac-containing medications while enrolled in the study.
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
- Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Subjects should be willing to shower using the same soap/cleansers between the screening visit and the end of the study, namely the Oil of Olay Moisturizing Bar Soaps with Shea Butter.
- Subjects should be willing avoid the use of body oils, creams, lotions, or powders to the test areas for a period of 48 hours before the application of patches.
Who cannot join
- Clinically significant abnormal values for hematology or chemistry at screening.
- History of current significant medical illness including (but not limited to) cardiovascular thrombotic events, myocardial infarction, stroke or other cardiac disease, hypertension, peptic ulcer disease or gastrointestinal bleeding, skin disorders, hematological disease, bronchospastic respiratory disease, asthma, diabetes mellitus, renal or hepatic insufficiency, or any other illness that the investigator considers should exclude the subject.
- History of atopic eczema, dry skin or ichthyosis.
- Excessive hair at the site of application that could possibly affect drug absorption; scar tissue, open tissue(s), tattoo or coloration that would interfere with the test sites, their assessments, and their reaction to drug, or that may compromised the safety of the subjects.
- Known allergies or hypersensitivity to Flector® Patch or diclofenac-containing products.
- Clinically significant abnormal physical examination and/or vital signs (e.g. systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg, heart rate >100 bpm and <45 bpm).
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- Received an investigational drug (including vaccines) within 60 days prior to study drug administration or are currently enrolled in an investigational study.
- Pregnant or breast-feeding.
- Recent history of surgery; within the past 3 months prior to screening.
- Clinically significant acute illness within 7 days prior to study drug administration.
- Donation of 1 or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 60 days prior to study drug administration.
- Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
- Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
- Over-the-counter or prescription use of other non-steroidal anti-inflammatory drug products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Dermal Microdialysis to Evaluate the Effect of Skin Properties and Application Site on the Topical Bioequivalence of Diclofenac: The Main Study
The investigators hypothesize that a technique called microdialysis can be used to measure the amount of the drug diclofenac which penetrates (enters) the fatty tissue under the skin. Microdialysis uses a small device called a 'probe' to determine the amount of drug which enters a body tissue. The small device is placed directly in the fatty tissue and samples are taken at specific times. The investigators will determine whether site of application affects the availability of the drug.
- Conditions
- Bioequivalence
- Being tested
- Reference, Patch location thigh, batch 1, Test, Patch location thigh, batch 2, Reference, Patch location abdomen, batch 1, Test, Patch location abdomen, batch 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference, Patch location thigh, batch 1Drug
Also called Flector patch
Reference, Patch location thigh, batch 1
Test, Patch location thigh, batch 2Device
Also called Microdialysis probe
Test, Patch location thigh, batch 2. Three probes will be inserted at each visit.
Reference, Patch location abdomen, batch 1Drug
Also called Flector Patch
Reference, Patch location abdomen, batch 1
Test, Patch location abdomen, batch 2Device
Also called Microdialysis probe
Test, Patch location abdomen, batch 2. Three probes will be inserted at each visit.
| Study group | Role | What they receive |
|---|---|---|
| Reference, Patch location thigh, batch 1 | Experimental | Reference, Patch location thigh, batch 1: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug. Receives: Drug: Reference, Patch location thigh, batch 1 |
| Test, Patch location thigh, batch 2 | Experimental | Test, Patch location thigh, batch 2: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug. Receives: Device: Test, Patch location thigh, batch 2 |
| Reference, Patch location abdomen, batch 1 | Experimental | Reference, Patch location abdomen, batch 1: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug. Receives: Drug: Reference, Patch location abdomen, batch 1 |
| Test, Patch location abdomen, batch 2 | Experimental | Test, Patch location abdomen, batch 2: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug. Receives: Device: Test, Patch location abdomen, batch 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood and tissue diclofenac concentrations
Blood and tissue concentrations (nanograms/milliliter) of the drug diclofenac will be measured and compared between different batches of the product Flector. In addition, the two batches will be compared at different application sites, namely the abdomen and thigh. Tissue concentrations will be measured using microdialysis.
Measured: 24 hours per visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Hartmut Derendorf, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592019
- Sponsor's protocol ID
- 10-223-00277-01
- Status last verified
- Nov 2012
- First submitted
- 30 Apr 2012
- Last updated
- 13 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dermal Microdialysis to Evaluate the Effect of Skin Properties and Application Site on the Topical Bioequivalence of Diclofenac: The Main Study
- ClinicalTrials.gov ID
- NCT01592019
- Acronym / sponsor ID
- 10-223-00277-01
- Conditions
- Bioequivalence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- Apr 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 4 May 2012 (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.
The investigators hypothesize that a technique called microdialysis can be used to measure the amount of the drug diclofenac which penetrates (enters) the fatty tissue under the skin. Microdialysis uses a small device called a 'probe' to determine the amount of drug which enters a body tissue. The small device is placed directly in the fatty tissue and samples are taken at specific times. The investigators will determine whether site of application affects the availability of the drug.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reference, Patch location thigh, batch 1 | Experimental | Drug: Reference, Patch location thigh, batch 1Reference, Patch location thigh, batch 1: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug. |
| Test, Patch location thigh, batch 2 | Experimental | Device: Test, Patch location thigh, batch 2Test, Patch location thigh, batch 2: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug. |
| Reference, Patch location abdomen, batch 1 | Experimental | Drug: Reference, Patch location abdomen, batch 1Reference, Patch location abdomen, batch 1: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug. |
| Test, Patch location abdomen, batch 2 | Experimental | Device: Test, Patch location abdomen, batch 2Test, Patch location abdomen, batch 2: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Males or females, between 18 and 55 years of age.
- Body mass index of 18.5 and 32 kg/m2, inclusive.
- Non-smoker (not smoked for 12 months prior to screening).
- Healthy on the basis of physical examination, medical history, and vital signs.
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel (including liver enzymes, other specific tests) and hematology are outside the normal reference ranges, the subject may be included only if the study physician judges the abnormalities or deviations from normal to be not clinically significant.
Key exclusion criteria (14 listed)
- Clinically significant abnormal values for hematology or chemistry at screening.
- History of current significant medical illness including (but not limited to) cardiovascular thrombotic events, myocardial infarction, stroke or other cardiac disease, hypertension, peptic ulcer disease or gastrointestinal bleeding, skin disorders, hematological disease, bronchospastic respiratory disease, asthma, diabetes mellitus, renal or hepatic insufficiency, or any other illness that the investigator considers should exclude the subject.
- History of atopic eczema, dry skin or ichthyosis.
- Excessive hair at the site of application that could possibly affect drug absorption; scar tissue, open tissue(s), tattoo or coloration that would interfere with the test sites, their assessments, and their reaction to drug, or that may compromised the safety of the subjects.
- Known allergies or hypersensitivity to Flector® Patch or diclofenac-containing products.
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 |
|---|---|---|
| Reference, Patch location thigh, batch 1Also: Flector patchReference, Patch location thigh, batch 1 | Drug | Reference, Patch location thigh, batch 1 |
| Test, Patch location thigh, batch 2Also: Microdialysis probeTest, Patch location thigh, batch 2. Three probes will be inserted at each visit. | Device | Test, Patch location thigh, batch 2 |
| Reference, Patch location abdomen, batch 1Also: Flector PatchReference, Patch location abdomen, batch 1 | Drug | Reference, Patch location abdomen, batch 1 |
| Test, Patch location abdomen, batch 2Also: Microdialysis probeTest, Patch location abdomen, batch 2. Three probes will be inserted at each visit. | Device | Test, Patch location abdomen, batch 2 |
Primary outcome
Blood and tissue diclofenac concentrations
Time frame: 24 hours per visit
Blood and tissue concentrations (nanograms/milliliter) of the drug diclofenac will be measured and compared between different batches of the product Flector. In addition, the two batches will be compared at different application sites, namely the abdomen and thigh. Tissue concentrations will be measured using microdialysis.
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 13 Dec 2012.
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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.
Hartmut Derendorf, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Reference, Patch location thigh, batch 1, Test, Patch location thigh, batch 2 and Reference, Patch location abdomen, batch 1 in people with Bioequivalence, run by University of Florida at 1 site in United States.
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 12 inclusion and 14 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 13 Dec 2012. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Blood and tissue diclofenac concentrations (time frame: 24 hours per visit). 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 13 Dec 2012.