Iconovo AB (publ) together with Amneal Pharmaceuticals Company GmbH and CBC Corporation India Pvt Ltd (fully owned subsidiary of CBC Co. Ltd, Japan) have carried out a clinical pharmacokinetic study to compare Iconovo´s generic product, ICOres budesonide/formoterol, to the original, SymbicortÓ TurbuhalerÓ. The plan for this study was announced in a PM dated 8 Nov 2018.
This pilot study, in line with its primary objective, demonstrated that the ICOres dry powder inhaler device functioned as intended clinically. The device delivered the appropriate quantity of the formulation during laboratory testing as well as in the clinical testing as evidenced by the plasma levels in study subjects. No accidental overdosing was noticed in the subjects. Read more