A Phase I, Randomized, Open-Label, Two-Way, Cross-Over Study Comparing the Safety, Tolerability and Pharmacokinetics of a Single Dose of Novel Dexamethasone Oral Dissolvable Film (ODF) with Fortecortin (Dexamethasone) Tablets in Healthy Subjects.

Trial Profile

A Phase I, Randomized, Open-Label, Two-Way, Cross-Over Study Comparing the Safety, Tolerability and Pharmacokinetics of a Single Dose of Novel Dexamethasone Oral Dissolvable Film (ODF) with Fortecortin (Dexamethasone) Tablets in Healthy Subjects.

Completed
Phase of Trial: Phase I

Latest Information Update: 21 Feb 2018

At a glance

  • Drugs Dexamethasone (Primary) ; Dexamethasone
  • Indications Acute asthma; Airway obstruction; Anaphylaxis; Chemotherapy-induced nausea and vomiting; Chronic obstructive pulmonary disease; Croup; Hypersensitivity
  • Focus Adverse reactions; Pharmacokinetics
  • Most Recent Events

    • 21 Feb 2018 New trial record
    • 03 Aug 2017 According to results published in the European Clinical Respiratory Journal, this study demonstrated the bioequivalence of innovative dexamethasone oral dissolvable film (ODF) (8 mg dexamethasone) compared to Fortecortin tablets (2x4 mg dexamethasone) as the pharmacokinetics parameters AUC(0-t), AUC(0-infinity) and Cmax met the acceptance limits of bioequivalence (i.e. all 90% CIs within 80-125 percentage).
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