Last updated on May 2019

Diazepam Buccal Film - Diastat Rectal Gel Crossover Study


Brief description of study

Randomized, multiple centers, single-dose, open-label, two-period, two-treatment, two-sequence crossover study under fed conditions. Each subject will receive both DBF and DRG administered according to weight category. DBF will be administered according to the currently recommended dose regimen (derived by Aquestive from population PK modeling in healthy volunteers). DRG will be administered depending on weight category according to the current product labeling for Diastat.

Clinical Study Identifier: NCT03953820

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Recruitment Status: Open


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