Qilu Pharmaceutical Initiates Bioequivalence Study of Palonosetron Hydrochloride Soft Capsules for Prevention of Acute Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Qilu Pharmaceutical Co., Ltd. has initiated a bioequivalence study evaluating the test formulation of Palonosetron Hydrochloride Soft Capsules compared with the reference formulation, Palonosetron Hydrochloride Soft Capsules (ALOXI®), in healthy adult subjects. The clinical trial registration number is CTR20253712, with the initial information disclosure date on September 19, 2025.

The drug is in the form of soft capsules, administered orally, one capsule per dose, as a single dose. It is cross-administered with the control drug, once per cycle. The purpose of this trial is to study the pharmacokinetics of a single oral dose of the test formulation compared to the reference formulation in healthy adult subjects under fasting/postprandial conditions and to evaluate the bioequivalence and safety of the two formulations when administered orally under fasting/postprandial conditions.

Palonosetron Hydrochloride Soft Capsules are a chemical drug, indicated for the prevention of acute nausea and vomiting symptoms caused by moderately emetogenic chemotherapy. Nausea and vomiting induced by moderately emetogenic chemotherapy are common adverse reactions to chemotherapy, with varying severity, affecting patients' quality of life and treatment compliance, necessitating pharmacological intervention for prevention.

The primary endpoint indicators of this trial include Cmax, AUC0-t, AUC0-∞; secondary endpoint indicators include effectiveness metrics such as Tmax, AUC_%Extrap, λz, t1/2, CL, Vd, F, as well as safety indicators like adverse events, serious adverse events, adverse reactions, vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms.

Currently, the experiment status is ongoing (not yet recruiting), with a target enrollment of 48 participants.

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Editor: Xiaolang Express