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

NCT06953453 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-25

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Principal Investigators

  • Haiyan Hu, doctor · Shanghai 6th People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2026-07-20
Completion
2026-08-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06953453 on ClinicalTrials.gov