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| ID | Type | Description | Link |
|---|---|---|---|
| REFLECTIONS B538-07 |
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This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to healthy male and female volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06410293 | Experimental |
| |
| Adalimumab-US | Active Comparator |
| |
| Adalimumab-EU | Active Comparator | Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06410293 | Biological | PF-06410293 will be administered as a single 40 mg, subcutaneous dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximal serum concentration (Cmax) | maximal serum concentration (Cmax) | Day 1 - Day 50 |
| area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) | area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) | 0-336 hours |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] | AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T) | Day 1 - Day 50 |
| AUC extrapolated to infinity (AUC0inf) | AUC extrapolated to infinity (AUC0inf) | Day 1 - Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters | Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters | Day 1- Day 71 |
| Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| De La Pedraja Radiology Associates | Coral Gables | Florida | 33134 | United States | ||
| SeaView Jacksonville |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Adalimumab-US | Biological | Adalimumab-US will be administered as a single 40 mg, subcutaneous dose |
|
| Adalimumab-EU | Biological | Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose |
|
Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) |
| Day 1- Day 71 |
| maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US | maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US | Day 1 - Day 50 |
| area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US | area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) for adalimumab EU as compared to adalimumab US | 0-336 hours |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US | AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T) for adalimumab EU as compared to adalimumab US | Day 1 - Day 50 |
| AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US | AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US | Day 1 - Day 50 |
| time to reach the maximum concentration (Tmax) | time to reach the maximum concentration (Tmax) | Day 1 - Day 50 |
| Apparent clearance (CL/F) | Apparent clearance (CL/F) | Day 1 - Day 50 |
| Apparent volume of distribution (Vz/F) | Apparent volume of distribution (Vz/F) | Day 1 - Day 50 |
| Terminal half-life (T1/2) | Terminal half-life (T1/2) | Day 1 - Day 50 |
| Jacksonville |
| Florida |
| 32256 |
| United States |
| SeaView Research, Inc. | Miami | Florida | 33126 | United States |
| SeaView Reseach Screening Office | Miami | Florida | 33134 | United States |
| SeaView Research, Inc. (Screening Office) | Miami | Florida | 33134 | United States |
| Vince & Associates Clinical Research, Inc. | Overland Park | Kansas | 66211 | United States |
| Vince & Associates Clinical Research, Inc. | Overland Park | Kansas | 66212 | United States |
| Prism Research, LLC | Saint Paul | Minnesota | 55114 | United States |
| ID | Term |
|---|---|
| C000631044 | PF-06410293 |
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