Phase I study evaluating the safety, tolerability and pharmacokinetics of a novel oral dissolvable film containing dexamethasone versus Fortecortin dexamethasone tablets

European Clinical Respiratory Journal

Bengt Westrin¹  Zuzana Diamant²  Leif Bjermer²  Gabriella Samuelsson Palmgren³ 

[1] AcuCort AB;Institute for Clinical Science, Skåne University Hospital;Skåne University Hospital;

关键词: dexamethasone;    drug formulation;    phase 1 clinical trials;    pharmacokinetics;    allergy;    anaphylaxis;   

DOI  :  10.1080/20018525.2017.1353395

来源: DOAJ

【 摘 要 】

Introduction: Systemic corticosteroids are anti-inflammatory agents with dexamethasone among the most potent in the class. Within (respiratory) allergy, systemic corticosteroids are usually applied in medical emergencies. In these situations, patients may experience physical or logistic problems taking tablets. To fulfil a practical unmet need for outpatients, Dexa ODF, an oral dissolvable film containing dexamethasone, was developed. Objectives: We compared the safety, tolerability and pharmacokinetics (PK) of Dexa ODF with Fortecortin tablets in healthy subjects. Methods: Thirty subjects participated in this open label, two-way, cross-over study, consisting of two treatment visits separated by 5–10 days. On both treatment visits, subjects randomly received one single dose of Dexa ODF (one strip; 8 mg dexamethasone) or one single dose of Fortecortin (two 4 mg tablets). Safety evaluations and blood sampling for PK were conducted until 48 h post-dose and bioequivalence analysis was performed on AUC(0-t), AUC(0-∞) and Cmax. Results: All subjects were dosed. Forty-five adverse events (AEs) were reported by 17 subjects and approximately 50% were deemed ‘possibly treatment related’ (14 on Dexa ODF; 12 on Fortecortin) with no significant difference between treatments. For all three bioequivalence parameters the 90% CIs were within the acceptance limits of bioequivalence (0.8;1.25). Conclusion: We demonstrated good tolerability and bioequivalence of Dexa ODF (8 mg dexamethasone) compared to Fortecortin tablets (2 × 4 mg dexamethasone). Dexa ODF is currently under development as an innovative treatment for use within respiratory and allergic conditions, including emergencies.

【 授权许可】

Unknown