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First received: June 09, 2023

Clinical Trial: A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Adalimumab

Study Type: INTERVENTIONAL


Official Title: A Randomized, Single-blind, Single-dose, 2-arm, Parallel-group Study to Determine the Pharmacokinetic Comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 mL (ABP 501-LC

Brief Summary: To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and maximum observed serum concentration (Cmax) in healthy adult participants.

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