Chemotherapy-Induced Nausea and Vomiting (CINV)

A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults

This is a single-center, single-dose, randomized, open-label, crossover study. Forty-two healthy male and female participants will be enrolled. The study will consist of 3 periods in which participants will receive either the test product QLM2010 (18 mL: aprepitant 130 mg and palonosetron hydrochloride 0.25 mg, manufactured by Qilu Pharmaceutical \[Hainan\] Co., Ltd.) or the Reference Product 1 (aprepitant injection CINVANTI®, 18 mL: 130 mg, manufactured by Alcami Carolinas Corp.) or the Reference Product 2 (palonosetron hydrochloride injection, 5 mL: 0.25 mg, manufactured by Dr Reddys Laboratories Ltd.) by intravenous injection under fasting conditions in each period. The washout period between 2 consecutive doses will be at least 14 days. Plasma concentrations of aprepitant and palonosetron at different sampling times will be determined by HPLC-MS/MS. Pharmacokinetic parameters will be calculated using noncompartmental analysis (NCA) and subjected to statistical analysis.

This study is a prospective, single-arm, multicenter, exploratory clinical trial divided into a screening phase, a treatment phase, and a follow-up phase. The study aims to evaluate the efficacy and safety of foslorapitant palonosetron for injection in preventing nausea and vomiting caused by treatment with recanituzumab. All patients who meet the inclusion criteria and do not meet any exclusion criteria are eligible for enrollment in this study and are scheduled to receive targeted therapy, antiemetic treatment, and follow-up. Dosage Regimen Eligible subjects will receive a prophylactic antiemetic regimen consisting of foslorapitant and palonosetron. The dosage regimen is as follows: Day 1 (D1): Foslorapitant and palonosetron (218 mg foslorapitant and 0.25 mg palonosetron hydrochloride), administered intravenously (IV) 1 hour prior to chemotherapy. Observe for two treatment cycles (C1-C2); Starting from the first dose, record the patient's daily vomiting frequency, severity of nausea, and medication adherence.

The primary objective of this clinical study is to evaluate the efficacy and safety of nanocrystalline megestrol acetate combined with a 5-HT3 receptor antagonist for the prophylaxis of nausea and vomiting caused by moderately emetogenic chemotherapy drugs. The study population consists of gastric adenocarcinoma patients who are scheduled to receive their first course of moderately emetogenic chemotherapy (PD-1/PD-L1 immune checkpoint inhibitors combined with the CAPOX regimen). This study is divided into two phases. The first phase is a single-arm study design, with the primary objective of preliminarily assessing the efficacy and safety of nanocrystalline megestrol acetate combined with a 5-HT3 receptor antagonist for the full-course management of nausea and vomiting caused by moderately emetogenic chemotherapy drugs. The second phase will adopt a randomized, controlled, multicenter trial design. Based on the efficacy and safety data from the first phase, the investigators will optimize the trial design (primarily including the primary endpoint and sample size calculation) to evaluate the efficacy and safety of nanocrystalline megestrol acetate compared with dexamethasone, each combined with a 5-HT3 receptor antagonist, for the prevention of nausea and vomiting caused by moderately emetogenic chemotherapy drugs.