Pharmacokinetic Evaluation of Intranasal Nalmefene
Sponsored by Opiant Pharmaceuticals Inc
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 5 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
* Male or female aged 18 to 55 years inclusive
* BMI ranging from 18 to 30 kg/m2, inclusive
* Adequate venous access
* Subjects must be non-smokers
Exclusion Criteria
* History of clinically significant disease
* Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
* Following an abnormal diet 4 weeks prior to screening
* Use of over the counter medications, dietary supplements, herbal products, vitamins or opioid analgesics 14 days before intervention
* Use of enzyme altering drugs 30 days before intervention
* Use of nasal products 28 days before intervention and throughout the study
* Previous or current opioid, alcohol, or other drug dependence
* Donated or received blood 30 days before intervention
* Women who are pregnant or breastfeeding at screening
* Women of childbearing potential unless surgically sterile or use effective contraception
* Current or recent upper respiratory tract infection
* Allergic to nalmefene
