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Aparna Mani
AZIDUS Laboratories Ltd, Research foundation in Rathinamangalam, Tamil Nadu, India
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Research Article
A Full Replicate in vivo Bioequivalence Study of Two Idelalisib 150 mg Tablets in Fasted Healthy Adult Human Subjects
Author(s): Arjun Arumugam*, Aparna Mani and Juan Chirinos
Background: Idelalisib, a PI3K small molecule inhibitor, specifically blocks the phosphatidylinositol-4, 5-bisphosphate 3-kinase catalytic subunit delta isoform (PI3Kδ). This is a potent drug which is specifically targeted for relapsed chronic lymphocytic leukemia (CLL). Methods and Findings: A full replicate bioequivalence study of two Idelalisib 150 mg tablets was conducted in 56 healthy adult human subjects under fasting conditions with a washout period of 10 days in between doses. Blood samples were collected up to 72 hours post-dose for measurement of pharmacokinetic parameters in all periods to quantify Idelalisib in human plasma using a validated LC-MS/MS method. Bioequivalence between both the products was established by calculating 90% confidence intervals (90% CI) for the ratio of Cmax and AUC0-t values .. View more»