Exploratory bioavailability of two formulations of gliclazide MR tablets 120 mg (I.R.I.S.) in healthy volunteers under fed and fasting conditions

Gliclazide is a medicine that reduces blood sugar levels. It is used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise and weight loss alone are not enough to keep blood sugar at the correct level.

Diabetes is a disease that occurs when the levels of blood sugar is too high. In type 1 diabetes, the body doesn’t make insulin (hormone that lowers the level of sugar in the blood). In type 2 diabetes, the body doesn’t make enough insulin or can’t use it as well as it should.

Gliclazide is available under several names including Diamicron® modified release (MR). It is already available in Europe and in many other countries around the world as MR tablets of 30 and 60 mg. Modified release tablet means that the active drug is released over several hours to maintain a constant amount of drug in the blood.

Gliclazide MR daily dose may vary from 30 mg to 120 mg. Currently, the patients requiring the highest dose of 120 mg should take 2 tablets of gliclazide MR 60 mg as a single dose at breakfast time. The availability of a 120 mg tablet would simplify the treatment. This may help the patients to stick to their treatment.

For this purpose, researchers are developing a new MR tablet containing 120 mg of gliclazide. The new tablet is designed in a way so that gliclazide gets absorbed in the body gradually and has a longer lasting action.

The aim of this study was to test if 3 different forms (fast, medium and slow release tablets) of 2 formulations of gliclazide MR 120 mg tablets (tablets A and B) were processed by the body of healthy participants in the same way as 2 Diamicron® MR 60 mg tablets.