DuoCort announces Phase I data presentation at the European Congress of Endocrinology
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- Published on Thursday, 26 April 2007 11:31
DuoCort AB today announced that results of the Phase I trial of its 5 mg
and 20 mg dual release hydrocortisone tablets for adrenal insufficiency
will be presented at the 9th European Congress of Endocrinology on
April 30 in Budapest. The trial evaluated the safety and
pharmacokinetics of the new hydrocortisone tablets in healthy
volunteers. The Phase I study showed that both the DuoCort 5 mg and 20 mg
hydrocortisone dual-release tablets were safe and well tolerated. The
novel dual-release formulation showed a rapid increase in cortisol
levels after single-dose administration, the dose was well absorbed and
it had similar bioavailability to the oral hydrocortisone in the
literature. Moreover, the data showed no risk of dose accumulation. The
release profile closely resembled the physiological one, including the
natural nocturnal cortisol free interval.
Based on the promising Phase I data, DuoCort is now launching its Phase II / III program.
"We are very pleased with the outcome of the Phase I trial, especially
as there was very little inter- or intra-individual variability in the
pharmacokinetics and the drug release profiles look very like the
physiological release profile of cortisol in healthy individuals,” said
DuoCort’s Chief Medical Officer, Dr Gudmundur Johannsson. “The Phase II
trial will seek to demonstrate similar safety, tolerability and
pharmacokinetics in patients, as well as gathering other safety and
quality of life data.”
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