Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy
Status:
Completed
Trial end date:
2020-03-11
Target enrollment:
Participant gender:
Summary
Open-label study to assess the pharmacokinetics of a single diazepam buccal film (DBF) dose
in 3 age cohorts of pediatric patients with epilepsy (age 2-5 years, age 6-11 years, and age
12-16 years). Subjects in the 6-11 years and 12-16 years age cohorts received a single DBF
dose during the interictal period (Period A) and ictal/peri-ictal period (Period B) with at
least 14 days washout between doses. Subjects in the age 2-5 years age cohort received a
single DBF dose only during the ictal/peri-ictal period (Period B).
Phase:
Phase 2
Details
Lead Sponsor:
Aquestive Therapeutics MonoSol Rx
Collaborators:
Covance Covance Central Laboratory Services inVentiv Health Clinical Syneos Health