An Open-Label, 2-Period, Fixed Sequence Study to Evaluate the Effect of Lansoprazole on the Pharmacokinetics of Neratinib in Healthy Subjects
Abstract
This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed conditions. To evaluate the effect of multiple doses of lansoprazole on the absorption and pharmacokinetics (PK) of a single dose of neratinib in healthy subjects.
Conditions: Healthy.
Primary outcome: AUC(0-t) of neratinib with and without lansoprazole; AUC(0-inf) of neratinib with and without lansoprazole; Cmax of neratinib with and without lansoprazole.
Enrollment: 15 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 15 participants or records.
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