Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteers

2019 ◽  
Author(s):  
Keyword(s):  
Clinical Study ◽  
Healthy Volunteers ◽  
Pharmacokinetic Profiles

Evaluation of the cognitive, psychomotor and pharmacokinetic profiles of rupatadine, hydroxyzine and cetirizine, in combination with alcohol, in healthy volunteers

2006 ◽  
Vol 21 (1) ◽  
pp. 13-26 ◽  
Author(s):  
Manuel J. Barbanoj ◽  
Consuelo García-Gea ◽  
Rosa Antonijoan ◽  
Iñaki Izquierdo ◽  
Ester Donado ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Pharmacokinetic Profiles

Mitigating target interference in bridging immunogenicity assay with target-blocking reagents and mild basic pH

Bioanalysis ◽  
2019 ◽  
Vol 11 (17) ◽  
pp. 1569-1580 ◽  
Author(s):  
Jihua Chen ◽  
John Garlits ◽  
Gangadhar Dhulipala ◽  
Thanoja Sirimanne ◽  
Colleen Xu ◽  
...  
Keyword(s):  
Clinical Study ◽  
Drug Target ◽  
High Tolerance ◽  
Minimal Impact ◽  
Pharmacokinetic Profiles ◽  
Positive Serum ◽  
Blocking Antibodies ◽  
Response Testing ◽  
Immunogenicity Assay ◽  
Positive Results

Background: Soluble drug target in clinical study samples generated false positive results in anti-drug antibody (ADA) bridging assays due to target-mediated bridging. Results: The combination of two target-blocking reagents and mild basic assay pH resulted in high tolerance to recombinant target protein and reduced levels of positivity in clinical study samples with pharmacokinetic profiles that did not indicate significant ADA response. Testing with low-affinity ADA positive serum from immunized rabbits and known ADA positive samples from nonclinical studies in rats confirmed the assay's ability to detect ADA positive samples and the minimal impact of basic pH and target-blocking reagents on ADA detection. Conclusion: These strategies provide alternatives for mitigating target interference when standard target-blocking antibodies alone are ineffective.

scholarly journals Randomized clinical study of safety, pharmacokinetics, and pharmacodynamics of RIPK1 inhibitor GSK2982772 in healthy volunteers

2017 ◽  
Vol 5 (6) ◽  
pp. e00365 ◽  
Author(s):  
Kathleen Weisel ◽  
Nicola E. Scott ◽  
Debra J. Tompson ◽  
Bartholomew J. Votta ◽  
Sujith Madhavan ◽  
...  
Keyword(s):  
Clinical Study ◽  
Healthy Volunteers ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Randomized Clinical Study

Buccoadhesive oxycodone hydrochloride disks: plasma pharmacokinetics in healthy volunteers and clinical study

1997 ◽  
Vol 44 (2) ◽  
pp. 137-142 ◽  
Author(s):  
Brunella Parodi ◽  
Eleonora Russo ◽  
Gabriele Caviglioli ◽  
Marisa Vallarino ◽  
Flavio Fusco ◽  
...  
Keyword(s):  
Clinical Study ◽  
Healthy Volunteers ◽  
Plasma Pharmacokinetics ◽  
Oxycodone Hydrochloride
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