Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/1/2014 |
| Start Date: | June 2013 |
| End Date: | January 2014 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06410293 and Adalimumab Sourced From US And EU Administered To Healthy Subjects
This healthy volunteers study will evaluate 210 subjects who will receive a single
sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European
Union). This study will involve sampling and pharmacokinetics evaluation of drug levels
following administration of PF-06410293 and the licensed adalimumab products.
sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European
Union). This study will involve sampling and pharmacokinetics evaluation of drug levels
following administration of PF-06410293 and the licensed adalimumab products.
Inclusion Criteria:
- Healthy male and female (non-childbearing potential). Healthy is defined as no
clinically relevant abnormalities identified by a detailed medical history, full
physical examination including blood pressure, pulse, ECG, and laboratory testing.
Exclusion Criteria:
- Evidence or history of clinically significant infectious, hematological, renal,
endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric,
neurologic, autoimmune, or allergic disease.
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