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Recruiting Phase 1 NCT06281951

Nebulized Fentanyl in Healthy Volunteers

Trial Parameters

Condition Analgesia
Sponsor University Hospital, Rouen
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 68 Years
Start Date 2024-04-26
Completion 2026-03-01
Interventions
Fentanyl - Inhalation by facial nebulizationFentanyl - Nebulisation

Brief Summary

Pain constitutes the predominant motive prompting individuals to seek emergency medical attention, accounting for 80% of admissions to emergency departments. Presently, it is imperative to employ expeditious and efficacious analgesia-sedation methodologies, obviating the necessity for intravenous administration, while ensuring the secure delivery of pharmaceutical agents. The objective of this study is to assess the feasibility and comfort of nebulized intranasal or facial aerosol administration of Fentanyl through the implementation of a pharmacokinetic/pharmacodynamic (PK/PD) study

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years and \< 68 years * BMI between 19 and 29 kg/m² * Affiliation to a social security scheme * Adult who has read and understood the information letter and signed the consent form * Woman capable of procreating (a woman is considered capable of procreating, i.e. fertile, after menarche and until she becomes menopausal, unless she is definitely sterile ) having very effective contraception (combined hormonal contraception (containing estrogens and progestins) associated with inhibition of ovulation, progestin-only hormonal contraception associated with inhibition of ovulation, intrauterine device, hormone-releasing intrauterine system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence) for 1 year and a negative urine pregnancy test at inclusion and during the duration of the study. * Woman definitely surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy). Postmenopausal woman: The postmenopausal state

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