What question did this study set out to answer?

To evaluate the single-dose pharmacokinetics, dose-proportionality, and food effect of oral 5 mg and 20 mg dual-release hydrocortisone tablets in healthy volunteers.

April 22, 2009European Journal of Endocrinology

Improving glucocorticoid replacement therapy using a novel modified-release hydrocortisone tablet: a pharmacokinetic study

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Authors

GJGudmundur JohannssonSahlgrenska University Hospital RBRagnhildur BergthorsdottirSahlgrenska University Hospital ANAnna G NilssonSahlgrenska University Hospital

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Implication

Randomized double-blind crossover trial demonstrates that once-daily dual-release hydrocortisone mimics physiological cortisol rhythms in healthy adults, indicating improved replacement therapy.

Key Points

To evaluate the single-dose pharmacokinetics, dose-proportionality, and food effect of oral 5 mg and 20 mg dual-release hydrocortisone tablets in healthy volunteers.
Randomised, double-blind, two-way cross-over phase I study in healthy volunteers comparing fasting 5 mg and 20 mg doses with betamethasone suppression, alongside an open-label food-interaction arm with a 20 mg dose taken after a high-calorie, high-fat meal.
Plasma cortisol concentrations were quantified using validated liquid chromatography–tandem mass spectrometry (LC-MS/MS) and immunoassay, with parameters evaluated via non-compartmental pharmacokinetic analysis.
Administration of the 20 mg tablet achieved clinically significant plasma cortisol (>200 nmol/l) within 20 minutes and reached a mean peak of 431 (s.d. 126) nmol/l within 50 minutes, with levels remaining >200 nmol/l for around 6 hours and falling below 50 nmol/l at 18–24 hours.
Food intake delayed the time to reach 200 nmol/l by 28 minutes based on LC-MS/MS and 9 minutes based on immunoassay, and plasma cortisol exposure between the 5 mg and 20 mg tablets was not fully dose proportional.

Cite This Study

Johannsson et al. (2009) studied this question.

synapsesocial.com/papers/6a70d8e0c2d7c3090826fbbc https://doi.org/10.1530/eje-09-0170

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Implication

Randomized double-blind crossover trial demonstrates that once-daily dual-release hydrocortisone mimics physiological cortisol rhythms in healthy adults, indicating improved replacement therapy.

Improving glucocorticoid replacement therapy using a novel modified-release hydrocortisone tablet: a pharmacokinetic study

Discussion

Member takes

Implication

Key Points

Cite This Study

Improving glucocorticoid replacement therapy using a novel modified-release hydrocortisone tablet: a pharmacokinetic study

Discussion

Member takes

Implication

Key Points

Cite This Study

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