A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Healthy Participants
A Randomized, Partially-blinded, Two-arm, Single-application, 3-way Crossover Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Subjects
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
- Drug: Duragesic (Fentanyl Transdermal System [TDS] Small Patches)
- Drug: New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)
- Drug: Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)
- Drug: Duragesic (Fentanyl TDS Large Patches)
- Drug: New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)
- Drug: Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Cypress, California, United States
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participant's source documents and initialed by the investigator
- A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) test at screening and urine pregnancy test at Day -1 of the first treatment period
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after completion of the study
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2), inclusive, and a body weight of not less than 50 kg
Exclusion Criteria:
- Participant has a history of or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); lipid abnormalities; significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal insufficiency (creatinine clearance below 60 milliliter per minute [mL/min]); thyroid disease; neurologic or psychiatric disease; infection; or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening as deemed appropriate by the investigator
- Use of medications or treatments that would significantly influence or exaggerate patch adhesion or that would alter inflammatory or immune response to the study product (example antihistamines, systemic or topical corticosteroids, cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG), monoclonal antibodies, radiation therapy)
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening. Participants must not use tobacco products, including all nicotine use, example, cigarettes, cigars, chewing tobacco, patch, gum
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Treatment Sequence (ACB) Position (RLR)
Participants will receive treatment A (Duragesic 12.5 microgram per hour [mcg/h]) applied to right paraspinal side in period 1, then treatment C (aged JNJ- 35685-AAA-G016 12.5 mcg/h) applied to left paraspinal side in period 2 and then treatment B (New JNJ-35685- AAA-G016 12.5 mcg/h) applied to right paraspinal side in period 3.
|
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (BAC) Position (RLR)
Participants will receive treatment B applied to right paraspinal side in period 1, then treatment A applied to left paraspinal side in period 2 and then treatment C applied to right paraspinal side in period 3.
|
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (CBA) Position (RLR)
Participants will receive treatment C applied to right paraspinal side in period 1, then treatment B applied to left paraspinal side in period 2 and then treatment A applied to right paraspinal side in period 3.
|
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (BCA) Position (RLR)
Participants will receive treatment B applied to right paraspinal side in period 1, then treatment C applied to left paraspinal side in period 2 and then treatment A applied to right paraspinal side in period 3.
|
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (CAB) Position (RLR)
Participants will receive treatment C applied to right paraspinal side in period 1, then treatment A applied to left paraspinal side in period 2 and then treatment B applied to right paraspinal side in period 3.
|
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (ABC) Position (RLR)
Participants will receive treatment A applied to right paraspinal side in period 1, then treatment B applied to left paraspinal side in period 2 and then treatment C applied to right paraspinal side in period 3.
|
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (ACB) Position (LRL)
Participants will receive treatment A applied to left paraspinal side in period 1, then treatment C applied to right paraspinal side in period 2 and then treatment B applied to left paraspinal side in period 3.
|
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (BAC) Position (LRL)
Participants will receive treatment B applied to left paraspinal side in period 1, then treatment A applied to right paraspinal side in period 2 and then treatment C applied to left paraspinal side in period 3.
|
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (CBA) Position (LRL)
Participants will receive treatment C applied to left paraspinal side in period 1, then treatment B applied to right paraspinal side in period 2 and then treatment A applied to left paraspinal side in period 3.
|
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (BCA) Position (LRL)
Participants will receive treatment B applied to left paraspinal side in period 1, then treatment C applied to right paraspinal side in period 2 and then treatment A applied to left paraspinal side in period 3.
|
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (CAB) Position (LRL)
Participants will receive treatment C applied to left paraspinal side in period 1, then treatment A applied to right paraspinal side in period 2 and then treatment B applied to left paraspinal side in period 3.
|
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (ABC) Position (LRL)
Participants will receive treatment A applied to left paraspinal side in period 1, then treatment B applied to right paraspinal side in period 2 and then treatment C applied to left paraspinal side in period 3.
|
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (DFE) Position (RLR)
Participants will receive treatment D (Duragesic 100 mcg/h) applied to right paraspinal side in period 1, then treatment F (aged JNJ-35685-AAA-G021 100 mcg/h) applied to left paraspinal side in period 2 and then treatment E (new JNJ-35685-AAA-G021 100 mcg/h) applied to right paraspinal side in period 3.
|
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (EDF) Position (RLR)
Participants will receive treatment E applied to right paraspinal side in period 1, then treatment D applied to left paraspinal side in period 2 and then treatment F applied to right paraspinal side in period 3.
|
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (FED) Position (RLR)
Participants will receive treatment F applied to right paraspinal side in period 1, then treatment E applied to left paraspinal side in period 2 and then treatment D applied to right paraspinal side in period 3.
|
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (EFD) Position (RLR)
Participants will receive treatment E applied to right paraspinal side in period 1, then treatment F applied to left paraspinal side in period 2 and then treatment D applied to right paraspinal side in period 3.
|
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (FDE) Position (RLR)
Participants will receive treatment F applied to right paraspinal side in period 1, then treatment D applied to left paraspinal side in period 2 and then treatment E applied to right paraspinal side in period 3.
|
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (DEF) Position (RLR)
Participants will receive treatment D applied to right paraspinal side in period 1, then treatment E applied to left paraspinal side in period 2 and then treatment F applied to right paraspinal side in period 3.
|
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (DFE) Position (LRL)
Participants will receive treatment D applied to left paraspinal side in period 1, then treatment F applied to right paraspinal side in period 2 and then treatment E applied to left paraspinal side in period 3.
|
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (EDF) Position (LRL)
Participants will receive treatment E applied to left paraspinal side in period 1, then treatment D applied to right paraspinal side in period 2 and then treatment F applied to left paraspinal side in period 3.
|
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (FED) Position (LRL)
Participants will receive treatment F applied to left paraspinal side in period 1, then treatment E applied to right paraspinal side in period 2 and then treatment D applied to left paraspinal side in period 3.
|
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (EFD) Position (LRL)
Participants will receive treatment E applied to left paraspinal side in period 1, then treatment F applied to right paraspinal side in period 2 and then treatment D applied to left paraspinal side in period 3.
|
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (FDE) Position (LRL)
Participants will receive treatment F applied to left paraspinal side in period 1, then treatment D applied to right paraspinal side in period 2 and then treatment E applied to left paraspinal side in period 3.
|
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
|
Experimental: Treatment Sequence (DEF) Position (LRL)
Participants will receive treatment D applied to left paraspinal side in period 1, then treatment E applied to right paraspinal side in period 2 and then treatment F applied to left paraspinal side in period 3.
|
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative Adhesion Percentage
Time Frame: Time of patch application up to patch removal (up to 72 hours)
|
The actual percentages of patch adhesion will be estimated according to the Food and Drug Administration (FDA) 0-4 scoring system.
An estimated percentage of adhesion, to a whole integer, will be obtained (FDA 0-4 [%] scoring) where 0=greater than or equal to (>=) 90% adhered (essentially no lift off the skin); 1= >= 75% to < 90% adhered (some edges only lifting off the skin); 2 = ≥ 50% to < 75% adhered (less than half of the patch lifting off the skin); 3 = > 0% to < 50% adhered but not detached (more than half of the patch lifting off the skin without falling off); 4 = 0% adhered - patch detached (patch completely off the skin).
|
Time of patch application up to patch removal (up to 72 hours)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to First Unacceptable Score
Time Frame: 12, 24, 36, 48, 60, and 72 hour following patch application
|
Time to first unacceptable score that is < 75% adhered will be assessed.
|
12, 24, 36, 48, 60, and 72 hour following patch application
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CR108060
- FENPAI1025 (Other Identifier: Janssen Research & Development, LLC)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
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