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Oral bioavailability of microdoses and therapeutic doses of midazolam as a 2-dimensionally printed orodispersible film in healthy volunteers.

Mareile H BreithauptEvelyn KrohmerLenka TaylorEva KoernerTorsten Hoppe-TichyJuergen BurhenneKathrin I FoersterMarkus DachtlerGerald HuberRakesh VenkateshKarin EggenreichDavid CzockGerd MikusAntje BlankWalter Emil Haefeli
Published in: European journal of clinical pharmacology (2022)
of the therapeutic dose of ODF-IS missed bioequivalence by a clinically not relevant extent. Prolonged mucosal exposure increased bioavailability. (Trial Registration EudraCT: 2020-003984-24, August 10, 2020).
Keyphrases
  • clinical trial
  • study protocol
  • phase iii
  • phase ii
  • room temperature
  • ulcerative colitis
  • double blind
  • placebo controlled