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Keep this study
Lead
Acorda Therapeutics
To determine the bioavailability of diazepam nasal spray versus diazepam rectal gel (Diastat®) under conditions of use in adolescent and adult persons with epilepsy (PWE) meeting the definition of refractory epilepsy.
Age
12–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of refractory epilepsy
Body weight 26 to 111 kilogram (kg) inclusive
You may not be if
Male or female subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product
Female subject who is pregnant, breastfeeding, or planning to become pregnant
Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
Clareo Health | Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
