Qilu Pharmaceutical Initiates Postprandial Bioequivalence Study of Entrectinib Capsules for Solid Tumors and NSCLC

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Qilu Pharmaceutical (Hainan) Co., Ltd. has initiated a postprandial bioequivalence study in healthy adult subjects to evaluate the test formulation of Entrectinib Capsules compared with the reference formulation of Entrectinib Capsules (Rozlytrek®). The clinical trial registration number is CTR20253435, and the initial information disclosure date was August 25, 2025.

The drug is in capsule form, administered orally, one capsule at a time, as a single dose, once per cycle, with cross-administration of the control drug. The primary objective of this trial is to study the pharmacokinetics of a single oral dose of the test formulation entrectinib capsule compared with the reference formulation entrectinib capsule (Rozlytrek®) in healthy adult subjects under fed conditions and to evaluate the bioequivalence of the two formulations when administered orally under fed conditions. The secondary objective is to assess the safety of the test and reference formulations in healthy subjects.

Entrectinib Capsules are a chemical drug, indicated for solid tumors and ROS1-positive locally advanced or metastatic non-small cell lung cancer. Solid tumors refer to abnormal masses that appear in the body and can be detected through imaging examinations; non-small cell lung cancer is a common type of lung cancer with symptoms such as cough and hemoptysis, and its diagnosis relies on imaging and pathological examinations.

The primary endpoint indicators of this trial include Cmax, AUC0 - t, AUC0 - ∞; secondary endpoint indicators include pharmacokinetic parameters such as Tmax, t1/2, λz, AUC_%Extrap, CL, Vd, F, as well as safety indicators like adverse events and serious adverse events.

Currently, the experiment is in progress (not yet recruiting), with a target enrollment of 32 participants.

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Editor: Xiaolang Express