About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Volunteer to participate, understand and sign the informed consent form before conducting the evaluation project;
Male or female subjects, aged between 18 and 55, including 18 and 55 years old;
Patients with malignant tumors diagnosed by histology or cytology;
Body Mass Index (BMI) is >21 kg/m2, but <30 kg/m2;
Disqualifiers
known or suspected allergy to opioids;
used opioids within 14 days before the first administration, including but not limited to: codeine, dihydrocodeine, hydromorphone, oxycodone, methadone, morphine, fentanyl and pethidine (pethidine);
plan to receive radiotherapy and / or systemic chemotherapy within 14 days before the first administration or during the study period (except for patients who receive immune checkpoint inhibitors or targeted drug maintenance therapy that is not a CYP3A4 inhibitor / inducer and whose condition is stable);
within 14 days before the first administration, the patient had received any monoamine oxidase (MAO) inhibitors (such as phenelzine, isocarbazine, chlorogiline, toloxadone, moclobemide, selegiline, rasagiline, etc.); Or have used CYP3A4 inhibitors (such as indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, nefazodone, ketoconazole, telithromycin, arepitan, erythromycin, fluconazole, grapefruit, verapamil, diltiazem, cimetidine, etc.) or CYP3A4 inducers (such as phenobarbital, carbamazepine, efavirenz, glucocorticoids, modafinil, nevirapine, oxcarbazepine, phenytoin, pioglitazone, rifabutin, rifampicin);
Trial design
Crossover
Treatments tested in this trial
Inhaled Fentanyl Aerosol
DrugThe 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.
Fentanyl Citrate Injection
DrugThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Cmax
Peak Concentration
Tmax
Time to Maximum Concentration
Ke
Terminal Elimination Rate
T1/2
Terminal elimination half-life
Secondary outcomes
Pupil diameter
Measure the pupil diameter using a pupillometer.
Sponsors and contacts
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