scholarly journals Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects

2007 ◽  
Vol 9 (2) ◽  
pp. R38 ◽  
Author(s):  
Lee Tay ◽  
Francisco Leon ◽  
George Vratsanos ◽  
Ralph Raymond ◽  
Michael Corbo
Keyword(s):  
Single Dose ◽  
Tetanus Toxoid ◽  
Healthy Subjects ◽  
Pneumococcal Vaccines ◽  
Open Label ◽  
Vaccination Response ◽  
Parallel Group Study ◽  
Parallel Group

scholarly journals A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab

2016 ◽  
Vol 76 (3) ◽  
pp. 526-533 ◽  
Author(s):  
Primal Kaur ◽  
Vincent Chow ◽  
Nan Zhang ◽  
Michael Moxness ◽  
Arunan Kaliyaperumal ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
Study Groups ◽  
Time Curve ◽  
End Points ◽  
Parallel Group Study ◽  
Parallel Group ◽  
The Usa ◽  
Abp 501 ◽  
Single Blind

ObjectiveTo demonstrate pharmacokinetic (PK) similarity of biosimilar candidate ABP 501 relative to adalimumab reference product from the USA and European Union (EU) and evaluate safety, tolerability and immunogenicity of ABP 501.MethodsRandomised, single-blind, single-dose, three-arm, parallel-group study; healthy subjects were randomised to receive ABP 501 (n=67), adalimumab (USA) (n=69) or adalimumab (EU) (n=67) 40 mg subcutaneously. Primary end points were area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) and the maximum observed concentration (Cmax). Secondary end points included safety and immunogenicity.ResultsAUCinf and Cmax were similar across the three groups. Geometrical mean ratio (GMR) of AUCinf was 1.11 between ABP 501 and adalimumab (USA), and 1.04 between ABP 501 and adalimumab (EU). GMR of Cmax was 1.04 between ABP 501 and adalimumab (USA) and 0.96 between ABP 501 and adalimumab (EU). The 90% CIs for the GMRs of AUCinf and Cmax were within the prespecified standard PK equivalence criteria of 0.80 to 1.25. Treatment-related adverse events were mild to moderate and were reported for 35.8%, 24.6% and 41.8% of subjects in the ABP 501, adalimumab (USA) and adalimumab (EU) groups; incidence of antidrug antibodies (ADAbs) was similar among the study groups.ConclusionsResults of this study demonstrated PK similarity of ABP 501 with adalimumab (USA) and adalimumab (EU) after a single 40-mg subcutaneous injection. No new safety signals with ABP 501 were identified. The safety and tolerability of ABP 501 was similar to the reference products, and similar ADAb rates were observed across the three groups.Trial registration numberEudraCT number 2012-000785-37; Results.

scholarly journals Effect of hepatic impairment on the pharmacokinetics of vilaprisan: An open‐label, single‐dose, parallel‐group study

2019 ◽  
Vol 85 (9) ◽  
pp. 2011-2021 ◽  
Author(s):  
Niladri Chattopadhyay ◽  
Kai Riecke ◽  
Sandra Ligges ◽  
Torsten Zimmermann ◽  
Atef Halabi ◽  
...  
Keyword(s):  
Single Dose ◽  
Hepatic Impairment ◽  
Open Label ◽  
Parallel Group Study ◽  
Parallel Group

Effects of hepatic impairment on the pharmacokinetics of nilotinib: An open-label, single-dose, parallel-group study

2009 ◽  
Vol 31 ◽  
pp. 2459-2469 ◽  
Author(s):  
Ophelia Q.P. Yin ◽  
Neil Gallagher ◽  
Chiaki Tanaka ◽  
Deirdre Fisher ◽  
Venkat Sethuraman ◽  
...  
Keyword(s):  
Single Dose ◽  
Hepatic Impairment ◽  
Open Label ◽  
Parallel Group Study ◽  
Parallel Group

An Open-Label, Single-Dose, Parallel-Group Study of the Effects of Chronic Hepatic Impairment on the Safety and Pharmacokinetics of Desvenlafaxine

2013 ◽  
Vol 35 (6) ◽  
pp. 782-794 ◽  
Author(s):  
Susan Baird-Bellaire ◽  
Jessica A. Behrle ◽  
Vernon D. Parker ◽  
Alain Patat ◽  
Jeffrey Paul ◽  
...  
Keyword(s):  
Single Dose ◽  
Hepatic Impairment ◽  
Open Label ◽  
Parallel Group Study ◽  
Parallel Group
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