An Drug-drug Interaction Study to Evaluate the Effects of Omeprazole 40mg on the Pharmacokinetics of SPRYCEL®
brief summary
A drug-drug interaction study designed to evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole in healthy, adult, human subjects
detailed description
A drug-drug interaction study and was designed to evaluate the drug-drug interaction between SPRYCEL® 100 mg (US sourced) and Omeprazole in healthy, adult, human subjects under fasted conditions at a time point when a high pH effect of omeprazole is expected, i.e., omeprazole at steady state and dasatinib are administered 9 hours apart. 18 healthy, adult, human subjects were enrolled into the study. Forty (40) PK blood sampling time points and a washout period of 05 days (between two administration of the study drug SPRYCEL® 100mg) were planned so that the drug concentration in the biological fluid could be characterized accurately for this drug interaction study.
official title
Open-label, Non-randomized, Two-treatment, Single-period, Single Dose, Drug-drug Interaction Study to Evaluate the Effects of Omeprazole 40mg on the Pharmacokinetics of SPRYCEL® 100 mg Film-coated Tablets (Dasatinib) in Adult Human Subjects