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| ID | Type | Description | Link |
|---|---|---|---|
| FENPAI1023 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants.
This is a single-center, randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), single application and 2-way Crossover (the same medications provided to all participants but in different sequence) pivotal study to determine the bioequivalence of marketed reference formulation DURAGESIC and the test formulation Fentanyl transdermal system (JNJ-35685-AAA-G021). Approximately 56 healthy participants will participate in this study. Participants will be randomly assigned to 1 of 2 treatment sequences. The study will consist of 3 parts: Screening Phase (within 21 days before the first study drug administration of the first period), an open-label treatment Phase consisting of 2 single-application treatment periods (26 days) and End-of-Study (at the end of Period 2). The total study duration for each participant will be from 43 days to a maximum of 59 days. Participants will receive a single application 100 microgram per hour (mcg/h) dose of DURAGESIC fentanyl transdermal system as Treatment A (Reference) and 100 mcg/h Fentanyl transdermal system (JNJ-35685-AAA-G021) as Treatment B (Test). Bioequivalence will be primarily evaluated by pharmacokinetic parameters. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment AB | Experimental | Participants will receive Treatment A (single application of DURAGESIC fentanyl transdermal system 100 microgram per hour (µg/h) dose) as Reference in Period 1; followed by Treatment B (single application of Fentanyl transdermal system [JNJ-35685-AAA-G021] 100 µg/h dose) as test in Period 2. A washout period of at least 8 days and no more than 14 days will be maintained between each treatment period. |
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| Treatment BA | Experimental | Participants will receive Treatment B [single application of Fentanyl transdermal system (JNJ-35685-AAA-G021) 100 microgram per hour (µg/h) dose] as test in Period 1; followed by Treatment A (single application of DURAGESIC fentanyl transdermal system 100 µg/h dose) as Reference in Period 2. A washout period of at least 8 days and no more than 14 days will be maintained between each treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Participants will receive single application of DURAGESIC fentanyl transdermal system 100 µg/h dose in one of the treatment periods. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Fentanyl | The Cmax is the maximum observed plasma concentration of Fentanyl. | Pre-dose; 0.5, 1, 2, 3, 5, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 73, 74, 78, 84, 94, 108 and 120 hours post-dose on Day 1 of each period |
| Time to Reach the Maximum Plasma Concentration (Tmax) of Fentanyl | The Tmax is the time to reach the maximum observed plasma concentration of Fentanyl. | Pre-dose; 0.5, 1, 2, 3, 5, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 73, 74, 78, 84, 94, 108 and 120 hours post-dose on Day 1 of each period |
| Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC[0-last]) Post Dose of Fentanyl | The AUC(0-last) is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration. | Pre-dose; 0.5, 1, 2, 3, 5, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 73, 74, 78, 84, 94, 108 and 120 hours post-dose on Day 1 of each period |
| Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of Fentanyl | The AUC (0-infinity) is the area under the plasma Fentanyl concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma Fentanyl concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant. | Pre-dose; 0.5, 1, 2, 3, 5, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 73, 74, 78, 84, 94, 108 and 120 hours post-dose on Day 1 of each period |
| Terminal Half-life (t[1/2]) of Fentanyl | Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z). |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Adherence Score of Fentanyl Transdermal System | The Food and Drug Administration (FDA) scoring system will be the basis to evaluate adhesion performance of the transdermal system. The scoring system has scale from 0-4. Where, 0 = system adhered to greater than or equal to (>=) 90 percent (%) adhered of the area, essentially no lift off the skin; 1 = system >=75% to less than (<) 90% adhered, some edges only lifting off the skin; 2 = system >=50% to <75% adhered, less than half of the patch lifting off the skin; 3 = system greater than (>) 0% to <50% adhered, more than half of the patch lifting off the skin but not falling off; 4 = system 0% adhered to skin, patch completely off the skin. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cypress | California | United States |
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| Fentanyl | Drug | Participants will receive single application of Fentanyl transdermal system (JNJ-35685-AAA-G021) 100 microgram per hour (µg/h) dose in one of the treatment periods. |
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| Pre-dose; 0.5, 1, 2, 3, 5, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 73, 74, 78, 84, 94, 108 and 120 hours post-dose on Day 1 of each period |
| Up to 72 hours post-dose on Day 1 of each period |
| Number of Participants with Adverse Events (AEs) and Serious AEs | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Screening up to End-of-Study (Approximately Day 59) |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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