NCT06953453

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Consenting patients who met inclusion and exclusion criteria were allowed to enter the study. The subjects will be randomly assigned (1:1) to receive an intravenous bolus (5 seconds) of 25μg fentanyl injection in the first cycle, and after a 2-week washout period, to receive a single dose of 25μg inhaled fentanyl aerosol through the Staccato delivery system in the second cycle; or to receive the same treatment in the opposite order.

Conditions

• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-23
• Primary completion: 2026-07-20
• Completion: 2026-08-20
• First posted: 2025-05-01
• Last updated: 2025-09-25

Locations

2 sites across 1 country: China