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RECRUITING
NCT06953453
PHASE1

A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors

Sponsor: Lee's Pharmaceutical Limited

View on ClinicalTrials.gov

Summary

This study is a single-dose, open-label, 2-cycle crossover design, comparing the pharmacokinetic parameters and safety of Inhaled Fentanyl Aerosol and intravenous fentanyl injection.

Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With Malignant Tumors

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-09-23

Completion Date

2026-08-20

Last Updated

2025-09-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Inhaled Fentanyl Aerosol

The subjects will be randomly assigned (1:1) to either dosing sequence: in the first cycle, receive an intravenous bolus (5 seconds) of 25μg Fentanyl injection, after at least a 2-week washout period, in the second cycle, receive a single dose of 25μg Fentanyl aerosol inhaler through the Staccato delivery system; or receive the same treatment in the reverse order.

DRUG

Fentanyl Citrate Injection

The subjects will be randomly assigned (1:1) to either dosing sequence: in the first cycle, receive an intravenous bolus (5 seconds) of 25μg fentanyl injection, after at least a 2-week washout period, in the second cycle, receive a single dose of 25μg fentanyl aerosol inhaler through the Staccato delivery system; or receive the same treatment in the reverse order.

Locations (2)

Henan Tumor Hospital

Zhengzhou, Henan, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China