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This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06410293 PFS (Prefilled Syringe) | Active Comparator | PF-06410293 40 mg administered by Prefilled Syringe (PFS) |
|
| PF-06410293 PFP (Prefilled Pen) | Active Comparator | PF-06410293 40 mg administered by Prefilled pen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06410293 PFS | Device | PF-06410293 40 mg administered subcutaneously by Prefilled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration (Cmax) | Day 1 - Day 15 | |
| Area under the concentration curve (AUC 0-2wk) | Day 1-Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose | Mean injection site pain over a 24 hour period post dose rated by subject on a visual analog scale (VAS), compared for injection by PFS or PFP, and for the 2 injection locations using each device | Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection |
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Inclusion Criteria:
All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Services, LLC | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33765358 | Derived | Cox DS, Alvarez DF, Bock AE, Cronenberger CL. Randomized, Open-Label, Single-Dose, Parallel-Group Pharmacokinetic Study of PF-06410293 (adalimumab-afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1166-1173. doi: 10.1002/cpdd.939. Epub 2021 Mar 25. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PF-06410293 PFP | Device | PF-06410293 40 mg administered subcutaneously by prefilled pen |
|
| Injection site tolerability (Blinded Safety Assessor - Modified Draize Scale) - Mean injection site tolerability over 24 hour post dose | Mean injection site tolerability using the Modified Draize Scale Numerical Grade over 24 hours post dose rated by the blinded Safety Assessor, compared for injection by PFS or PFP, and for the 2 injection locations using each device | 1, 3, 8, 12 and 24 hours post injection |
| Time to reach the maximum serum concentration (Tmax) | Day 1 - Day 43 |
| AUC from time 0 to the last time point with quantifiable concentration (AUCT) | Day 1 - Day 43 |
| AUC extrapolated to infinity (AUC0 inf) | Day 1 - Day 43 |
| Volume of distribution (Vz/F), | Day 1 - Day 43 |
| Apparent clearance (CL/F) | Day 1 - Day 43 |
| Terminal half life (t1/2) | Day 1 - Day 43 |
| To obtain contact information for a study center near you, click here. | View source |