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News
2010-03-10
Levodose® - Positive results of clinical study
A clinical trial, where Levodose® was compared with two standard tablet preparations, for treatment of Parkinsons disease, has now succesfully been completed. The objective of the study was to compare the bioavailability of Levodose® (20 micro-tablets corresponding to a total dose of 100mg levodopa) with two reference products -Madopark® Quick and Sinemet® and to determine their bioequivalence. The clinical study was conducted at Karolinska University Hospital.
The study was a single dose, phase I study in 18 healthy volunteers. All subjects received three treatments, one with each dosage form, and blood samples were frequently collected and analysed for plasma concentrations of the active ingredients, levodopa and carbidopa.
The outcome of the study was to full satisfaction and in accordance with the expectations. The result that Levodose® and Sinemet® are shown to be bioequivalent, following single dosing, means that it is possible to file an application for marketing authorisation of Levodose®.
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2010-03-10
Levodose® - Positive results of clinical study
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