Pharmacokinetics and safety of the antitumor drug everolimus in healthy Chinese subjects: a single-dose, open-label, randomized, two-sequence, two-period crossover, phase I bioequivalence study.

Authors: Chen X, Yi X, Liu Y, Wang X, Peng Y, Wang Q, Shuai Y, Zhang H.

DOI: 10.3389/fphar.2025.1718032

Abstract Summary

A Chinese bioequivalence study confirmed that generic everolimus matches the reference drug in healthy subjects. Food significantly delayed absorption (0.75h to 3h) and reduced bioavailability, though elimination remained unchanged (~37-38h half-life). Both formulations met bioequivalence criteria with no serious adverse events reported.

Why Brain? 🧠

Study confirms generic everolimus matches original drug in Chinese patients, showing food delays absorption but doesn’t affect elimination. Both formulations proved bioequivalent and safe.

License: CC BY.

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