QLM2010 Comparative Pharmacokinetic Study With 2-Minute Intravenous Administration

This is a single‐center, single‐dose, randomized, open‐label, crossover study. Forty‐twohealthy male and female participants will be enrolled. The study will consist of 3periods in which participants will receive either the test product QLM2010 (18 mL:aprepitant 130 mg and palonosetron hydrochloride 0.25 mg, manufactured by QiluPharmaceutical [Hainan] Co., Ltd.) or the Reference Product 1 (aprepitant injectionCINVANTI®, 18 mL: 130 mg, manufactured by Alcami Carolinas Corp.) or the ReferenceProduct 2 (palonosetron hydrochloride injection, 5 mL: 0.25 mg, manufactured by Dr ReddysLaboratories Ltd.) by intravenous injection under fasting conditions in each period. Thewashout period between 2 consecutive doses will be at least 14 days. Plasmaconcentrations of aprepitant and palonosetron at different sampling times will bedetermined by HPLC‐MS/MS. Pharmacokinetic parameters will be calculated usingnoncompartmental analysis (NCA) and subjected to statistical analysis.