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

ConditionCancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorLee's Pharmaceutical Limited

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

Qualifiers

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

Treatments tested in this trial

  • Inhaled Fentanyl Aerosol
  • Fentanyl Citrate Injection

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators