Actively Recruiting
A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors
Led by Lee's Pharmaceutical Limited · Updated on 2025-09-25
100
Participants Needed
2
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers who understand and sign informed consent
- Male or female aged 18 to 55 years, inclusive
- Diagnosed with malignant tumors by histology or cytology
- Body Mass Index (BMI) greater than 21 kg/m2 and less than 30 kg/m2
- Adequate hematopoietic and organ function within 14 days before randomization, including absolute neutrophil count ≥1.5×10^9/L, platelet count ≥80×10^9/L, hemoglobin ≥90 g/L, creatinine clearance ≥30 ml/min, liver enzymes and bilirubin within specified limits, coagulation INR ≤1.5 ULN
- Oxygen saturation (SaO2) >95% without oxygen support and pulmonary function with FEV1/FVC >70% and FEV1 >80% predicted
- Agree to effective contraception during the study and for one month after stopping treatment; female patients of childbearing age must have a negative blood pregnancy test before administration
- ECOG performance status score of 0 to 1
You will not qualify if you...
- Known or suspected allergy to opioids
- Use of opioids within 14 days before first administration
- Planned radiotherapy or systemic chemotherapy within 14 days before first administration or during the study, except stable immune checkpoint inhibitors or targeted maintenance therapy
- Use of monoamine oxidase inhibitors or CYP3A4 inhibitors or inducers within 14 days before first administration
- Participation in other clinical studies or surgery within 30 days before screening or planned surgery during study
- Smoking more than 10 cigarettes per day within 3 months before screening
- History of drug or alcohol dependence or abuse within 2 years before screening
- Frequent consumption of xanthine-rich foods or drinks (e.g., more than 5 cups of coffee daily)
- Hypotension (systolic <90 mmHg or diastolic <60 mmHg) or uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg)
- Positive tests for HBV DNA, HCV RNA, HIV antibodies, or syphilis antibodies
- Positive alcohol or urine drug test at any study visit
- Expected survival less than 1 year
- Clinically significant ECG abnormalities
- History of lung diseases excluding lung malignancies
- History of unstable angina, syncope, coronary artery disease, myocardial infarction, heart failure, stroke, transient ischemic attack, or major neurological diseases
- Presence of meningeal or CNS metastasis requiring intervention or malignancy-related epilepsy
- Positive pregnancy test or lactation in women of childbearing age
- Any other condition that may affect informed consent, protocol compliance, study results, or participant safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Henan Tumor Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
2
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233
Not Yet Recruiting
Research Team
H
Haiyan Hu, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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