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NOT YET RECRUITING
NCT07817004
PHASE1

QLM2010 Comparative Pharmacokinetic Study With 2-Minute Intravenous Administration

Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-09

Completion Date

2026-12

Last Updated

2026-09-14

Healthy Volunteers

Yes

Interventions

DRUG

apripitant and palonosetron injectable emulsion

This is the test product involved in this study.

DRUG

palonosetron hydrochloride injection

This is the second reference drug involved in this study, named as R2.

DRUG

apripitant injection (CINVANTI)

This is the first reference product, named as R1