Relative oral bioavailability and tolerability of hydrocortisone from 2-dimensionally printed orodispersible films in children and adolescents with primary adrenal insufficiency (REPLACE trial)

Conditions

adrenal insufficiency

Brief summary

The GMR of the AUC of orally administered hydrocortisone ODF compared to the AUC of hydrocortisone oral tablets.

Detailed description

Descriptive PK parameters of all IMP formu-lations, e.g. AUC, Cmax, the time to Cmax (tmax), and the apparent volume of distribu-tion (Vz/F)., Correlation of concentrations of salivary cor-tisone and hydrocortisone with serum free cortisone and hydrocortisone., Evaluation of palatability by assessing partic-ipants satisfaction and ease of administra-tion of hydrocortisone ODF., Evaluation of frequency, severity, serious-ness, relatedness, expectedness, and out-come of AE under trial medication., Evaluation of the concentration-time profiles of the following biomarkers after different hy-drocortisone formulations: o plasma ACTH as well as glucose and electrolytes (sodium, potassium) in blood gas analysis, Evaluation of the amount of urine hydrocorti-sone excretion within 8 h for all formulations.

Related papers

No related papers found yet.

Interventions

DRUGAcecort 5 mg Filmtabletten

DRUG2D printed Hydrocortisone orodispersible films

DRUGAcecort 1 mg Filmtabletten

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The GMR of the AUC of orally administered hydrocortisone ODF compared to the AUC of hydrocortisone oral tablets.	—

Secondary

Measure	Time frame
Descriptive PK parameters of all IMP formu-lations, e.g. AUC, Cmax, the time to Cmax (tmax), and the apparent volume of distribu-tion (Vz/F)., Correlation of concentrations of salivary cor-tisone and hydrocortisone with serum free cortisone and hydrocortisone., Evaluation of palatability by assessing partic-ipants satisfaction and ease of administra-tion of hydrocortisone ODF., Evaluation of frequency, severity, serious-ness, relatedness, expectedness, and out-come of AE under trial medication., Evaluation of the concentration-time profiles of the following biomarkers after different hy-drocortisone formulations: o plasma ACTH as well as glucose and electrolytes (sodium, potassium) in blood gas analysis, Evaluation of the amount of urine hydrocorti-sone excretion within 8 h for all formulations.	—

Measure

Time frame

Descriptive PK parameters of all IMP formu-lations, e.g. AUC, Cmax, the time to Cmax (tmax), and the apparent volume of distribu-tion (Vz/F)., Correlation of concentrations of salivary cor-tisone and hydrocortisone with serum free cortisone and hydrocortisone., Evaluation of palatability by assessing partic-ipants satisfaction and ease of administra-tion of hydrocortisone ODF., Evaluation of frequency, severity, serious-ness, relatedness, expectedness, and out-come of AE under trial medication., Evaluation of the concentration-time profiles of the following biomarkers after different hy-drocortisone formulations: o plasma ACTH as well as glucose and electrolytes (sodium, potassium) in blood gas analysis, Evaluation of the amount of urine hydrocorti-sone excretion within 8 h for all formulations.

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Outcome results

None listed