{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["18(3)"],"submitter":["Gonzalez M"],"pubmed_abstract":["This two-sequence, three-period study (NCT04645940) was designed to evaluate the effect of food and concomitant rabeprazole, a proton pump inhibitor, on the pharmacokinetics (PK) and safety of fruquintinib and its metabolite M11 after a single oral dose of fruquintinib 5 mg in healthy subjects. In the food effect treatment periods, 14 subjects were randomized in a 1:1 ratio utilizing a two-sequence (fed/fasted vs. fasted/fed), two-period, cross-over design. Fruquintinib was administered on Day 1 (Period 1) and Day 15 (Period 2). In the drug-interaction period (Period 3), all subjects received rabeprazole 40 mg 1 h prior to fruquintinib under fasted conditions, following a 6-day lead-in of rabeprazole 40 mg once daily. PK samples to measure fruquintinib and M11 were collected pre-dose and o"],"journal":["Clinical and translational science"],"pagination":["e70168"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11903327"],"repository":["biostudies-literature"],"pubmed_title":["Assessment of Food Effect and pH-Dependent Drug-Drug Interactions of Fruquintinib in Healthy Subjects."],"pmcid":["PMC11903327"],"pubmed_authors":["Chien C","Yang Z","Gonzalez M","Schelman WR","Gupta N","Zhou X"],"additional_accession":[]},"is_claimable":false,"name":"Assessment of Food Effect and pH-Dependent Drug-Drug Interactions of Fruquintinib in Healthy Subjects.","description":"This two-sequence, three-period study (NCT04645940) was designed to evaluate the effect of food and concomitant rabeprazole, a proton pump inhibitor, on the pharmacokinetics (PK) and safety of fruquintinib and its metabolite M11 after a single oral dose of fruquintinib 5 mg in healthy subjects. In the food effect treatment periods, 14 subjects were randomized in a 1:1 ratio utilizing a two-sequence (fed/fasted vs. fasted/fed), two-period, cross-over design. Fruquintinib was administered on Day 1 (Period 1) and Day 15 (Period 2). In the drug-interaction period (Period 3), all subjects received rabeprazole 40 mg 1 h prior to fruquintinib under fasted conditions, following a 6-day lead-in of rabeprazole 40 mg once daily. PK samples to measure fruquintinib and M11 were collected pre-dose and o","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Mar","modification":"2026-07-15T14:39:47.253Z","creation":"2025-04-04T09:06:52.801Z"},"accession":"S-EPMC11903327","cross_references":{"pubmed":["40077903"],"doi":["10.1111/cts.70168"]}}