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A Single‐Dose, Open‐Label, Randomized, Four‐Sequence, Four‐Period, Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability of Single Doses of Clobazam Oral Soluble Film (COSF) with Clobazam Tablets (CTAB)

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Trial Profile

A Single‐Dose, Open‐Label, Randomized, Four‐Sequence, Four‐Period, Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability of Single Doses of Clobazam Oral Soluble Film (COSF) with Clobazam Tablets (CTAB)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Jan 2019

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At a glance

  • Drugs Clobazam (Primary) ; Clobazam
  • Indications Lennox-Gastaut syndrome
  • Focus Pharmacokinetics; Registrational
  • Sponsors Aquestive Therapeutics

    • Most Recent Events

    • 20 Dec 2018 According to an Aquestive Therapeutics media release, the data was presented at the American Epilepsy Society 2018 Annual Meeting in early December.
    • 02 Nov 2018 According to an Aquestive Therapeutics media release, the U.S. Food and Drug Administration (FDA) approved SYMPAZAN (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
    • 24 Oct 2018 According to results published in the Epilepsia Journal, clobazam oral soluble film (COSF) at single doses of 10 and 20 mg was bioequivalent to clobazam tablets (CTAB) at equivalent doses for both clobazam and its active metabolite N-desmethylclobazam.
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