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

PHASE1RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 23, 2025

Primary Completion Date

July 20, 2026

Study Completion Date

August 20, 2026

Conditions
Cancer
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.

Trial Locations (2)

200233

NOT_YET_RECRUITING

Shanghai Sixth People's Hospital, Shanghai

450008

RECRUITING

Henan Tumor Hospital, Zhengzhou

Sponsors
All Listed Sponsors
lead

Lee's Pharmaceutical Limited

INDUSTRY